FDA Issues Class I Recall for Zimmer M/L Taper Hip Implants
June 21, 2015
A Class I recall for the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks has recently been issued by officials at the U.S. Food and Drug Administration (FDA). This recall is the most serious type of recall the FDA can issue, as it signifies that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Why the Zimmer Hip Implants Have Been Recalled
The reason that the FDA is taking such aggressive action to take these devices off of the U.S. market is that they reportedly have higher than expected amounts of manufacturing residues left on them. According to Zimmer, it discovered this issue when a “process monitoring failure” came to light.
For people who have had these recalled devices implanted, they could develop serious health complications, which may include (but may not be limited to):
- Serious allergic reactions
- Severe hip pain
Those who develop such complications will likely need revision surgery to remove the implant.
Zimmer has reported that, to date, it has not received any reports that patients have been injured as a result of these recalled devices. Nevertheless, the FDA is encouraging physicians and the general public to report any problems they experience with these devices.
Zimmer Hip Implant Recall: Here’s What Else You Should Know
- The recalled devices, which would have been implanted during a hip replacement surgery, may have been used in conjunction with other devices.
- A complete list of the lot numbers impacted by this recall can be viewed here.
- Distributors and hospitals were reportedly notified about this recall on May 18, 2015. These parties are reportedly quarantining and inventorying the recalled hip implants to prepare them to send back to Zimmer.
Portland Personal Injury Attorney at the Savage Law Firm
Have you been injured by a faulty or defective medical device? If so, you can rely on an experienced Portland personal injury attorney at the Savage Law Firm for experienced help and aggressive legal advocacy. For more than three decades, our lawyers have been devoted to providing each of our clients with personal attention, respect and the highest quality legal services.
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Categories: Product Liability