Articles Posted in Recalls

The FDA admitted yesterday what plaintiffs’ lawyers have known forever (sorry). Following several recalls of the artificial hip parts, the U.S. health regulator said that metal-on-metal hip implants can cause tissue damage and pain that many necessitate surgery to replace the hip implant.

The hope was just the opposite, of course. Metal-on-metal hip implants were thought to be more durable. Unfortunately, instead of really testing this thesis, the hip implant manufacturers decided it would be best to try it out on real life humans. Shockingly, lawsuits ensued.

What Happens to Metal on Metal Hips Replacements?

Metal hip implants dispel metal into the body because the metal is rubbing together. This is not exactly an unforeseeable development that was discovered a few thousand years ago. Zimmer, Biomet, Smith and Nephew, Wright, Zimmer, Johnson & Johnson and Wright Medical never got the memo, I guess. The metal floating around can cause damage to the bone and soft tissue surrounding the implant. The metal particles may also wear down the implant itself.

There would be a Lance Armstrong and Oprah vibe to all of this if these manufacturers would just recall these hip replacements AND admit responsibility. We have done well on the former, but they still defend these train wreck devices in litigation.

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Yesterday, Subaru announced the recall of 633,842 vehicles in order to check for a problem with a fuse in a puddle light that could short-circuit and lead to a fire. The potential fire hazard occurs when moisture containing road salt gets into the lamp housing and makes contact with the circuit board.

The vehicles affected by this recall are the Subaru Legacy and Subaru Outbacks, made in 2010 and 2011; as well as the 2006 – 2012 Subaru Tribeca and 2009 – 2012 Subaru Forester.

According to Subaru spokesman Michael McHale, the company believes that 54,000 vehicles are actually equipped with the small accessory lamps under the side of the vehicle.

Zimmer Spine will recall a medical device that is used during spinal fusion surgery, as it has been determined that it may break inside of a patient’s body, causing internal injuries and blood loss. You are dealing with someone spine, you are taking about losing blood and internal injuries… this is not good.

The Zimmer PEEK Ardis Inserter is used to implant the PEEK Ardis Interbody Spacer, a device used in posterior spinal fusion procedures. The inserters are being recalled because Zimmer Spine has received reports of PEEK Ardis Interbody Spacer implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery. Zimmer estimates from reports that the inserters appear to be breaking at a rate of about 0.52%, or one out of approximately every 200.

The recall affects all lots of the PEEK Ardis Inserter, including inserters in the Ardis Instrument Set with part number 3256-01 and Specialty Ardis Inserters with part numbers:

Zimmer Spine has announced the recall of a medical device that is used during spinal fusion surgery, as it has been determined that it may break inside of a patient’s body, causing internal injuries and blood loss. Ummm…wow, that can’t be good.

The Zimmer PEEK Ardis Inserter is used to implant the PEEK Ardis Interbody Spacer, a device used in posterior spinal fusion procedures. The inserters are being recalled because Zimmer Spine has received reports of PEEK Ardis Interbody Spacer implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery. Zimmer estimates from reports that the inserters appear to be breaking at a rate of about 0.52%, or one out of approximately every 200.

The recall affects all lots of the PEEK Ardis Inserter, including inserters in the Ardis Instrument Set with part number 3256-01 and Specialty Ardis Inserters with part numbers:

Last week, the FDA announced a recall on 32-milligram single intravenous (IV) doses of Zofran because of the potential for serious cardiac risks.

What is the problem with this anti-nausea drug that has brought about relief for so many? The FDA says Zofran can cause an irregular heart rhythm called prolonged QT interval when taken in such high doses. This condition can result in a potentially fatal rhythm problem known as Torsades de Pointes, an uncommon and distinctive form of polymorphic ventricular tachycardia.

Back in June, GlaxoSmithKline released a study that led them to instantly update their warning to warn of the risk of heart arrhythmias. At that time, Glaxo removed 32-mg single doses from the drug’s label.

A small number of motorcycle helmets are being recalled as they fail to meet government impact standards and might not adequately protect motorcycle riders in the event of a crash.

The recall affects GLX 501C motorcycle helmets made by Galaxy Helmets in Irwindale, California, and affects the extra-large size only. According to the National Highway Traffic and Safety Administration (NHTSA), Galaxy Helmets will notify helmet owners and will bring the flawed GLX 501C helmets into safety compliance, free of charge. Galaxy has not, however, stated when the notification to its customers or repair process to its helmets will begin.

Consumers can contact Galaxy Helmets at 626-359-0900 or here for more information.

The U.S. Consumer Product Safety Commission (CPSC) has announced the recall of approximately 23,400 trampolines, manufactured by Sportspower Ltd., and sold exclusively at Sports Authority.

It has been determined that the trampoline’s metal legs can move out of position and puncture the jumping area, posing a risk of injury. Sportspower is aware of one incident, though no injuries have been reported.

This recall involves Sportspower Parkside model TR-14FT-COM trampolines. The trampolines are 14 feet in diameter and were sold with an enclosure net. The trampolines have blue or light blue fabric on the safety matting and enclosure pole sleeves. The model number is marked on the packaging and instruction manual. “Parkside” is printed on the enclosure net.

At least five thousand window fittings manufactured by G-U Yapi of Turkey and distributed by G-U Hardware, Inc. have been recalled. The Consumer Product Safety Commission announced the window could fall due to defective fittings. G-U is working with affected consumers to replace the fittings. One injury from falling windows has been reported so far.

The Consumer Product Safety Commission (CPSC) has announced the recall of Champion Power Equipment Portable Generators due to a fire hazard.

The recall affects Champion Power Equipment Portable Generators as it has been determined that fuel can leak from the generator’s carburetor, posing a fire hazard. The recall affects approximately 8,600 generators.

The recall involves two models of Champion Power Equipment portable generators, both of which have a black frame with black and yellow control panels, a bar handle and two wheels.

You’ve probably had your head stuck in the sand if you haven’t heard of the massive recall of peanut butter products over the last month that have been linked to a salmonella outbreak.

Late last month, the FDA linked a salmonella outbreak to peanut butter, produced for Trader Joe’s, to Sunland Inc. Sunland operates the country’s largest USDA certified organic peanut processing plant. Though the illnesses have only been linked to the Trader Joe’s product, Sunland has recalled everything made in the plant since March 2010 – a total of 240 products. Now, Sunland hopes to reopen it peanut processing and roasting facility within a week to ten days, though it could be six to eight weeks before peanut butter production resumes.

The FDA has stepped up investigations of peanut facilities after a 2007 outbreak sickened more than 400 people who ate peanut butter processed at a facility in Nebraska. After this occurrence, peanut butter was identified by the FDA as a high-risk food. This has not been the first of problems for a Sunland plant. FDA records show two inspections in 2009 and 2010 that found “objectionable conditions” at the plants.

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