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Metal on Metal Hip Replacement Recalls List

Written by Class Action Lawyer on . Posted in Product Recall News

Depuy Implant Recalls (Now a Subsidiary of Johnson and Johnson) This implant manufacturer was a part of the 2001 recall of zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest. The recall was mandated by the Food and Drug Administration after numerous reports that the femoral head component was fracturing at a larger rate than what was expected. Depuy Orthopedics was one of the eight manufacturers that issued recalls of their hip implant systems as a result of using St. Gobain Desmarquest’s zirconia ceramic femoral heads in their joint replacement products.

In the late 1990s, Depuy withdrew its Hylamer Polyethylene Bearing Surface product from the market. This product was originally developed to minimize wear in join implant components for the hip, shoulders, knees, and elbows. In 2001, the British government’s Medical Devices Agency issued a recall of knee implant Hylamer liners sterilized with gamma radiation in air. The recall was conducted after a study showed that patients were showing a high failure rate for the device.

In 2008, Depuy issued another recall on its LCS Knee – Orthopedic knee implant Meniscal bearing insert. This product is intended to replace a knee joint in order to relieve pain and restore function to the knee. The reason for the recall was that the product was not labeled properly and mis-etched as to size.

Smith & Nephew Implant Recalls
This London based medical device manufacturer issued a recall of its Genesis II and Profix II Knee Implants to the Food and Drug Administration in 2003. The recall was a result of the failure of the knee implant systems to bond properly to the bone when implanted. This caused increased pain and loosened joints in patients with the knee implant systems. The failure of these knee implant products led a number of patients to have additional surgeries to fix the problem. These additional surgeries resulted in longer rehabilitation times for the patient and also heightened risks during the operation.

In 2007, Smith & Nephew issued another recall after a subscontractor incorrectly packaged the medical manufacturer’s BIRMINGHAM Hip Resurfacing System implants. As a result of the subcontractor error, different sizes of acetabular cups were packaged together.

Smith & Nephew began another voluntary recall in January of 2008 of its TC-PLUS, VKS, and RT-PLUS product lines. The medical implant manufacturer was informed by one of its suppliers that the semi-finished knee implant castings contained higher-than-specified iron content. The products being recalled were manufactured by Smith & Nephew’s subsidiary, Plus Orthopedics.

Biomet Implant Recalls
Biomet was a part of the 2001 recall of zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest. As mentioned previously, this recall was initiated after authorities had found that the component was breaking at a rate that was higher than expected.

In 2007, Biomet issued a recall of its Tibial Bearing ARCOM UHMWPE, sterile. The reason for this recall was improper laser etching for size.

In 2008, Biomet issued another recall. This recall was on its Biomet brand Modular Microplasty Cup Insterter which is an instrument for its hip prosthesis acetabular cup component. The reason for the recall was that the weld at the lock location could break during impaction.

Encore Orthopedics Recalls
Encore was also a part of the 2001 recall of St. Gobain Desmarquest manufactured zirconia ceramic femoral heads.

In 2004, Encore Orthopedics initiated a recall due to labels being switched on two of its products, Foundation Knee System, and 3DKnee System. The 3D Knee System products were labeled as Foundation Knee Systems and the Foundation Knee Systems were labeled as 3D Knee Systems.

In 2008, Encore Orthopedics recalled its Foundation Knee System Tibial Fixed Impactor component. The reason for the recall is that the company began to receive reports from surgeons that the Nitronic 60 screw on the Tibial Fixed Impactor was fracturing during surgery. Encore initiated another recall in 2008 on its 3DKNEE Tibial Insert Trial, a device used in surgery to determine the right size of 3DKnee component to implant. The Tibial Insert Trial was being incorrectly marked for thickness.

Howmedica Implant Recalls (A Subsidiary of Stryker, Corp.)
Howmedica was one of the manufacturers that had to recall its products due to St. Gobain Desmarquest manufacturing problem with its femoral heads.

In early 2008, Stryker issued a recall on its Trident Hip Implants. The FDA issued a warning in 2007 to Stryker Corporation after patients were complaining that the implant was causing “squeaky hips” and joint pains. Patients were also reporting that the implants were even breaking and causing the individual difficulty when performing simple tasks such as walking. The complications that some patients were experiencing caused them to have additional surgeries in an attempt to remedy the situation. The recalled implants were being manufactured at the company’s Ireland facility and sold in the United States. The FDA claims that Stryker failed to fix manufacturing problems which led to problems in patients. According to the FDA, the following list of Stryker products could be defective due to the manufacturing issues:

Stryker issued a recall of the following products:

    Trident Acetabular PSL Cup
    Trident Hemispherical Cup

 

Sulzwer
Sulzer Orthopedics, a subsidiary of Sulzer Medica, issued a recall in 2001 after the company found a manufacturing error with its knee implant systems. The implants were being contaminated with an oil residue during the manufacturing process. The lubricant residue inhibited the ability for the implant to bond efficiently to neighboring bone. Sulzer reached a $750 million settlement with patients in the United States for this manufacturing error due to the fact that thousands of individuals had to undergo additional surgeries.

Wright Medical Recalls
In 2004, Wright Medical issued a recall on its metal acetabular hip cups that are used in the company’s CONSERVE(R) Total and CONSERVE(R) Plus hip systems. The reason for the recall was a manufacturer defect that resulted in a seam or ridge in the inner acetabular cup surface. This defect caused the component to fail.

 

Zimmer Recalls
Zimmer was another medical manufacturer that was a part of the St. Gobain Desmarquest manufacturing problem with its zirconia ceramic femoral heads.

In 2008, Zimmer issued a recall on its Durom Cup Replacement product after thousands of the product had already been used in thousands of patients since its approval in 2006. Physicians began to see a problem in their patients when some started complaining about continuous pain after the normal healing timeframe. A number of these patients were forced to have revision surgeries to repair the problem. A few months after the recall, Zimmer’s Durom Cup Replacement was back on the market. However, this time they posted additional product training on their website for physicians. Zimmer claimed that this new training would teach surgeons on how to use their product properly which would cut down on problems. Zimmer admits that it did a poor job at training doctors on using its product when it was first released. Zimmer’s shareholders were also unhappy with the fact that the company took a long time to even notify its stakeholders of the current issues with the Durom Cup product. The company’s shareholders filed a class action lawsuit in response to Zimmer’s way of handling the situation.

In June of 2008, Zimmer issued another recall, however this time the recall was on its NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor. The Tibial Broach Impactor is an instrument used during knee surgery. The firm issued the recall due to findings that the instrument could potentially break during surgery and could leave fragments of metal in the patient’s knee.

Another recall was issued in 2008 for another Zimmer surgical instrument: the Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument. This instrument is used during knee arthroplasty surgeries. This instrument was recalled due to the fact that it could fracture during surgery.

Other Hip replacement recalls:

The entities include: Advanced Bioresearch Association, a regulatory affairs firm consulting with medical device and pharmaceutical companies American Ortomed Corporation, now dissolved Biomet Inc., makers of the M2a-Magnum™ System Large Metal Articulation (Total MOM Hip) and ReCap (Resurfacing Femoral Head , not MOM system), and others no longer marketed C.R. Bard Inc., no current MOM system DePuy Orthopaedics, Inc., a Johnson & Johnson company, makers of ASR (Total Hip, Resurfacing, Recalled); Pinnacle Metal-on-Metal (Total Hip with Ultamet Insert), and others no longer marketed. Downs Surgical Ltd., no current MOM system Encore Medical, now DJO Surgical, makers of metal-on-metal liners for use with FMP acetabular system, and others no longer marketed Endomedics, Inc., no current MOM system Implantology Corporation, no current MOM system Joint Medical Products Corporation, acquired by Johnson & Johnson April 1, 1995 Link America, Inc., no current MOM system Med-Tek Corporation, no current MOM system Orthopaedic Device Corporation, no current MOM system Orthopaedic Manufacturing Company, no current MOM system Osteotechnology, Inc., no current MOM system Pfizer, Inc., no current MOM system Stryker Orthopaedics for Howmedica Osteonics Corp., markets the Cormet Resurfacing System in the US; MITCH PER Mini Hip (resurfacing, not marketed in US) and others no longer marketed Synergy Orthopaedics Intl., Inc., no current MOM system Techmedica, Inc., no current MOM system Turnkey Intergration USA, Inc., no current MOM system Waldemar Link GMBH & Co. KG, no current MOM system Wright Medical Technology, Inc., DYNASTY® Acetabular Cup System with A-CLASS® Metal-on-Metal; Conserve (Partial Resurfacing); Conserve Plus (Total Resurfacing) and others no longer marketed

Coopervision Avaira Toric Contact Lense Recall, Torn Corneas

Written by Class Action Lawyer on . Posted in Product Recall News

Torn corneas, vision problems follow 'stealth recall' of contact lenses

By JoNel Aleccia
Amid growing reports of eye problems ranging from blurry vision to torn corneas, federal health officials are threatening to issue a public warning about recalled contact lenses manufactured by CooperVision Inc. and sold widely at stores such as Costco, Wal-Mart and LensCrafters.
The Fairport, N.Y., firm has yet to heed a request from the federal Food and Drug Administration to broaden notification of problems with certain lots of its Avaira Toric contact lenses, which were recalled quietly in August because of unidentified “residue.” On Tuesday, CooperVision officials said the recall affected about 600,000 contact lenses, or 10 percent of those sold or issued as samples in the United States.
“Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses,” FDA spokeswoman Morgan Liscinsky said in an e-mail.
But for at least a dozen consumers who indicated to msnbc.com they have suffered impaired vision, excruciating pain or landed in emergency rooms after wearing the contacts launched in April and recalled in August, such notice is long overdue.
 
“It is very frustrating that they’re not more vocal about it and that the FDA hasn’t warned more people,” said Mellisa Cotton, 40, of Atlanta, who said she suffered two corneal abrasions this summer after wearing Avaira Toric contact lenses.
“Next to labor, a corneal abrasion is one of the most painful things you can have," said the mother of two.
Dan O’Neil, 0, of Hampton, Va., said his 15-year-old daughter, Erin, had to be rushed to the local ER on Aug. 21 after using Avaira Toric contact lenses from a newly opened box from Wal-Mart.
"I noticed what first looked like a torn piece of contact on her eye," he said. "Upon closer examination, I realized that what I was seeing was Erin's cornea torn and rolled back."
Doctors confirmed a severe tear and the girl was treated with pain medication and antibiotics. Only after she was injured did O'Neil and his wife learn of the recall.
"The ophthalmologist didn't even seem to be aware of it," he said, adding later.  “Any time your kid’s vision is affected, you’re going to worry.”
CooperVision Inc. officials issued a voluntary U.S. recall on Aug. 19 of what the company called “a limited number of lots” in the U.S. market. On Aug. 25, the company notified the FDA of the recall, officials said.
CooperVision officials said they initiated the recall after investigating a “small number of unexpected wearer reports of hazy vision and discomfort.”
A notice posted on the company’s website includes a fill-in box where customers can check to see if their lots are affected. However, it does not include a list of retailers or a complete list of affected lots.
Major retailers said they notified their customers quickly about the Avaira Toric recall. About 2,600 Costco customers who bought the lenses were notified on or soon after Aug. 19, said Craig Wilson, vice president for food safety and quality assurance. Wal-Mart notified its optical departments on Aug. 24, said spokeswoman Dianna Gee. A LensCrafters spokeswoman who didn’t want to give her name said the company notified customers immediately through its retail stores.
Those moves, however, followed wider international notification of the defective lenses, including recalls issued in Hong Kong, Australia and in Spain, where the public notice included a list of more than 200 affected lots of lenses. The Hong Kong notice indicates that Avaira Toric lenses were also recalled in Canada, Germany, and Italy.
But the company has yet to issue wider notification in the U.S. that the FDA has the authority to seek, but not demand. “We are requesting that the firm issue a broader statement to ensure that users are aware of the recall,” Liscinsky, the FDA spokeswoman, wrote in an e-mail.
CooperVision officials, did not respond to msnbc.com questions about why they had not complied with the FDA request.  In a statement, a firm spokeswoman said that the company “has fully cooperated with the FDA and continues to closely monitor the situation and seek advice from FDA during this process." The company's stock, traded as COO, fell on Tuesday.
Critics say that CooperVision has downplayed the recall of hundreds of lots of contact lenses in the United States, exposing vulnerable consumers to ongoing injury.
Phyllis Entis, author of the blog eFoodAlert, which tracks public safety recalls, has been following the Avaira Toric situation since August, documenting what she said “can only be described as a stealth recall.”
The blog includes reports from several consumers who have reported injuries and other problems with Avaira Toric contact lenses from August through October.
They include Deirdre Shapiro, 43, of Villanova, Pa., who said she suffered hazy vision and a scratched cornea that "felt like someone was in there with a sharp instrument stabbing my eye."
She wore the contacts for months, until September, when her doctor finally notified her of the recall.
"Literally, my whole summer, I thought I was going crazy," she said. "I wish I'd known. I would never have put this thing near my eye."
 
Class Action lawyer Network Lawyers acepting cases from Adults and Children with Torn Corneas. Calls are coming in daily from people injured by the Avaira Toric Contact Lenses

 

Avaira Contact Lense Recall Update Calls Flood our Lines

Written by Class Action Lawyer on . Posted in Product Recall News

Class action lawyer Network Attorneys are  accepting Avaira Contact lense recall cases. There has been an increase in calls from people injured by the Avaira Contact lenses. Avaira Contact lense attorneys reviewing cases. Suprisingly is the number of children effected by this recall.

Avaira recall
By JoNel Aleccia
Nearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.
CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company's Pleasanton, Calif., office. Denise Powell, a company spokeswoman, said the line produced 6.6 million Avaira Sphere lenses affected by the recall, but 4.9 million were actually shipped.

The move comes after the federal Food and Drug Administration issued a Class I warning about the products and pressured the company last month to increase public notice about the recall of nearly 780,000 Avaira Toric lenses. Class I recalls are the most serious kind and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
As of late October, the FDA had received at least 40 reports of problems associated with various CooperVision contact lenses, agency records show. At least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere, according to data shared by Phyllis Entis, who maintains the eFoodAlert blog. An FDA official was not available to discuss the new recall Tuesday.
Dozens of Avaira Toric users reported problems ranging from hazy vision and pain to severe injuries, including torn corneas, which required emergency medical treatment. Company officials were accused of issuing a "stealth recall" in August that left many consumers unaware of the problem.
Company officials noted that no product lines other than Avaira Toric and Avaira Sphere use silicone oil to manufacture the products. The firm expects to set aside a reserve of $9 million for the costs of the expanded recall. All told, the company expects to spend $23.2 million on the Avaira recalls, according to the press release. 
Consumers with problems or questions related to the recalls should contact the company at 1-855-526-6737 [Call: 1-855-526-6737] . The firm says it has reached out to affected consumers to ensure their safety.

Class Action Lawyer Network is receiving calls and emails daily from adults and children injured by tthe Coopervision Avaira contact lenses. Many are discussing physician diagnosis of corneal damage. This appears to be serious and widespread. If you or a loved one has been injured by the Coopervision Avaira Contact lense recall contact Class Action lawyer network immediately to have your case reviewed by a lawyer on our Avaira contact lense team.

Toyota Seatbelt Recall Class Action

Written by Class Action Lawyer on . Posted in Product Recall News

Toyota Defective Seat Belt Lawsuit ,Toyota seatbelt recalls, Toyota seatbelt class action

Toyota announced a recall of 57,000 Lexus luxury vehicles due to defective seat belts in certain 2005 or 2006 models. The recalled Lexus models include GS430, GS350, IS250 and IS350.

Latch failures

This is where although the latch is believed to be locked into the buckle (in many cases you can even hear the definite "click") when the belt itself is under any kind of force, it will unlatch itself and be rendered useless.

Spool outs

This is when the inertia reel of the seat belt doesn't lock tightly. This may not at first become apparent as it may well be working. However when a sudden jolt is felt on the belt, it may not lock in correctly and restrain you.

Latch plate problems

This is when the seatbelt may be buckled up fine, but on the event of an impact the latch plate will come away from the buckle undoing the seat belt.

 

NEWS ALERT

AP)  Toyota is recalling 1.3 million vehicles worldwide due to a seat belt defect. The recall includes more than 130,000 Yaris models sold in the U.S.

Toyota Motor Sales USA says it is working with the National Highway Traffic Safety Administration to recall 134,900 model-year 2006 and 2007 Yaris subcompact cars. The automaker says in severe front-end collisions, the seat belt is at risk of causing a foam pad in the vehicle to ignite.

NEWS ALERT

Southern California – LOS ANGELES DAILY JOURNAL

Five inches made the difference between 36-year-old Jian Zhong Yang walking away from a car accident and being left a quadriplegic, his attorney, Garo Mardirossian, claims.

Yang's 1992 Toyota Paseo lap belt anchor was five inches forward of where it needed to be to protect a short, slight man like Yang, the Los Angeles attorney contends. And Toyota Motor Corp. is to
blame, he charges.

As soon as today, Mardirossian begins trying to convince jurors in a downtown Los Angeles courtroom that a design defect in the seat belt was what paralyzed his client.

He seeks at least $30 million in economic damages and additional punitive damages.

 

It is one thing to actually not wear a seat belt (rightly or wrongly), that is the decision of the driver. However, if you put your safety belt on with the understanding that it is going to protect you, when you have the misfortune to be involved in a vehicle impact and it doesn't…. then that is another matter altogether. The problem is that defective seat belts may seem perfectly fine until the point when they are expected to carry out their job. These is the findings of several Toyota defective seatbelt lawsuits that have been filed. The bottom line is that evidence of a faulty seat belt system can be notoriously difficult to detect by sight. It is only after the restraining system has malfunctioned, and that is too late. And once a person has been injured or killed by a faulty restraint system, it's obviously too late. Toyota defective seat belt lawsuits are being won, so there is light at the end of the tunnel. However, this is not very comforting to all the people who have been severely injured and even killed because of them. Many are left in wheelchairs and will need ongoing care for the rest of their lives. Class Action lawyer network has a specific Department for Toyota and vehicle malfunctions causing injury and wrongful death.

    Call now for Lawyers for Toyota Seat Belt Failures
             Attorneys for Toyota Seat Belt Problems

 Injuries that can happen if seatbelts don't work properly.

  • Head Injury from failed  Toyota Seat Belt
  • being ejected from the vehicle
  • Toyota Seat Belt Lawyer Neck and Back Injuries
  • Paralysis/Spinal Cord Injury Toyota Seat Belt Lawyers
  • Internal Injury Toyota Seat Belt
  • Toyota Seat Belt lawyer  Broken Bones
  • Wrongful Death

 

Seat belt failure is a serious problem and danger. Contact your Toyota seat belt lawyers now and get the justice you've been waiting fo

 

FDa Recalls Updated

Written by Class Action Lawyer on . Posted in Product Recall News

    CareFusion EnVe Ventilators: Class I Recall – Potential for Interruption of Patient Ventilation Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. Posted 11/04/2011
    Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy UPDATED 11/04/2011. FDA is asking health professionals to remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to MedWatch. Originally posted 04/14/2011

Listeria Cantaloupe Recall lawyers

Written by Class Action Lawyer on . Posted in Product Recall News

Rocky Ford Cantaloupe Listeria Recall
On September 14, 2011, Jensen Farms announced a cantaloupe recall brought about by concern of listeria cantaloupe contamination. So far, approximately 25 people have died from bacteria linked to the listeria cantaloupe recall, which has affected people in 20 states. The Rocky Ford cantaloupe were shipped by Jensen Farms between July 29, 2011 and September 10, 2011.


The US Food and Drug Administration (FDA) issued a warning to people not to eat whole cantaloupe shipped by Jensen Farms due to concerns the cantaloupes are contaminated with listeria and could be linked to a listeriosis outbreak. As of October 7 at least 120 people have reportedly been affected by Listeria monocytogenes and approximately 25 people have died. One miscarriage has been linked to the listeriosis outbreak, while four illnesses associated with pregnancy have also been tied to the cantaloupe. According to reports, one newborn was born with a listeria infection.

Listeriosis is a rare and serious illness caused by eating food contaminated with Listeria. Symptoms of listeriosis include fever and muscle aches. Although listeriosis is not necessarily fatal, it can be life-threatening to people with compromised immune systems, people with certain chronic medical conditions, newborns, and elderly people. Listeriosis can also cause miscarriage, stillbirth or serious illness when a contaminated product is ingested by a pregnant woman.

People who think they may have been affected by contaminated cantaloupe should seek medical attention. Symptoms can take a month or two to appear. In addition to fever and muscle aches, symptoms can include headache, stiff neck, confusion, diarrhea, and/or nausea.

Because cantaloupes have a shelf life of approximately two weeks, it is unlikely that any recalled cantaloupes are still on store shelves. Symptoms may still arise.

On October 19, the FDA announced that water on the floor of the farm and dirty equipment were likely the causes of the listeria outbreak. Investigators reportedly found samples of listeria bacteria on equipment at the Jensen Farms packing facility. The FDA noted the equipment was corroded, dirty and difficult to clean. Furthermore, pools of water formed near the packing equipment, which may have allowed the bacteria to survive. The equipment was purchased in July and had previously been used to wash and dry potatoes. The FDA also noted that Jensen Farms did not use a "pre-cooling" process to cool the cantaloupe, which may have allowed moist conditions to remain on the cantaloupe, allowing listeria to grow.

Cantaloupe recall
The cantaloupe may be labeled: Colorado Grown, Distributed by Frontera Produce, USA, Pesticide Free, Jensenfarms.com, Sweet Rocky Fords. The cantaloupes are packed in cartons that are labeled: Frontera Produce, www.fronteraproduce.com or with Frontera Produce, Rocky Ford Cantaloupes. Both cartons also include: Grown and packed by Jensen Farms Granada, CO and Shipped by Frontera Produce LTD, Edinburg, Texas. Not all of the recalled cantaloupes are labeled with a sticker. Consumers should consult the retailer if they have questions about the origin of a cantaloupe.

The recalled cantaloupes are known to distributed in the following states: IL, WY, TN, UT, TX, CO, MN, KS, NM, MO, NE, OK, AZ, NJ, NY, PA. There may be other states as well.

Listeria Cantaloupe Lawyers of Class Action Lawyer Network are ready to help you
Lawsuits have reportedly been filed alleging people were harmed by the strain of Listeria linked to the cantaloupe recall. Among those are families who say the deaths of their loved ones were caused by contaminated cantaloupe.

Cantaloupe Listeria
If you or a loved one has suffered listeria, food poisoning, wrongful death other side effects from  infected  Cantaloupe call for a free case evaluation in Illinois, Wyoming, Tennessee, Utah, Texas, Colorado, Minnesota, New Mexico, Montana, Nebraska, Oklahoma, Arizona, New Jersey, New York, Pennsylvania, or other locations.