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Class I Recall of Zimmer Biomet Shoulder Replacement Device Issued

Zimmer Biomet Shoulder Replacement Lawsuit »
Class I Recall of Zimmer Biomet Shoulder Replacement Device Issued

 Zimmer Biomet, an Indiana-based medical device company specializing in shoulder replacement implant devices, has recently had to recall more than 3,000 of their artificial shoulder replacement implants. Increased rates of medical device reports, suggesting that the implants have a high likelihood of post-op fracturing, lead the FDA to initiate this Class I recall. A Class I recall is the most serious recall issued by the FDA indicating a serious risk of serious injuries or even death.

The Biomet Comprehensive Reverse Shoulder replacement device will fracture inside the patient’s shoulder, leaving the patient with little-to-no shoulder motor function and risk of continued injury. To resolve the issue, healthcare practitioners have had to resort to a post-operational surgical correction, an invasive process that can lead to potential harms including “permanent loss of shoulder function, infection, or rarely, death” as explained by an FDA report.

According to reports from Zimmer’s recall, the issue seems to stem from a malfunction in the Comprehensive Reverse Shoulder device’s “humeral tray”, a composing piece that has a tendency to break away from the device. According to Zimmer, their product does carry a consumer warning label. However, the company has stated, “the devices are fracturing at a higher rate than is stated in the labeling.”

The company first issued the recall in December 2016, urging healthcare institutions to “quarantine” all remaining Comprehensive Reverse Shoulder replacement devices. There are nearly 3,660 devices still on the market that Zimmer is still working to recover.

This is the second time that the same device has been pulled from the market. The first recall occurred in 2010 when Biomet, which has since been bought out by Zimmer, was forced to pull their Comprehensive Reverse Shoulder replacement device from the market due to the high reports of post-op fracturing. Just like the current product, it was the device’s humeral tray that had a tendency to break away from the device after surgery.

Neither Zimmer nor the FDA has issued statements on how they plan to address serving the patients who have already received the recalled devices.

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Litigation Updates

Class I Recall of Zimmer Biomet Shoulder Replacement Device Issued

February 15, 2020
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February 15, 2020

Class I Recall of Zimmer Biomet Shoulder Replacement Device Issued

First Zimmer Shoulder Replacement Case Settled

February 22, 2016
Learn More

February 22, 2016

First Zimmer Shoulder Replacement Case Settled

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I have had many speed bumps to get over on information needed to file my claim that has had me stressing out several times, but once I have gotten in touch with TorHoerman Law I always come out with most of my problems handled. Nikki has been very much helpful in aiding me with my complaint and never lets me go feeling like I’m clueless as to what to do next. She listens and responds very efficiently and with very positive attitude and that’s always helpful. Thanks TorHoerman Law for your advice and support I appreciate all y’all have done for me.

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I was in a car accident and went to the Personal Injury Team at TorHoerman Law. I met with Kristie Stephens and she was awesome, keeping me informed of what was going on, what to expect and not to hesitate to call if I need any questions answered. The staff I came in contact over the phone was Kristine Stephens, and she guided me through the whole process. I suggest the Personal Injury Team at TorHoerman Law for anybody that needs help with legal action.

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TorHoerman Law was responsible for handling a medical case for our family. I was extremely impressed with their professionalism and ability to react quickly. They also did a nice job keeping us updated with the case throughout the process. This was the first time experiencing a situation like this and Tor Hoerman law did an excellent job from start to finish.

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They contacted me the next day. Very nice people!

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