Zimmer Biomet Shoulder replacement device was found to have a higher risk of fracturing than it was earlier believed, consumers at risk.
Labeling of the Zimmer Biomet Shoulder replacement failed to adequately disclose fracture risks. Those who received the shoulder replacement may experience substantial pain and suffering.
The Biomet Comprehensive Reverse Shoulder recall, was issued as Class I. Class I recalls are reserved for some of the most serious recalls issued by FDA.
Loss of shoulder movement
In December, Zimmer Biomet sent a recall notice and a Certificate of Acknowledgement to all affected customers.
Those with adverse events or side effects related to the use of these products are urged to report such problems.
If you or a family member have received the Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340, you may be entitled to compensation. Connect with an attorney at Medical Claim Legal.
The Zimmer Biomet shoulder device is facing a class 1 recall from the FDA.
Due to a “higher fracture rate than stated” the Food and Drug Administration (FDA) has issued a class one recall of the Zimmer Biomet reverse shoulder device. Such recalls are reserved for products that “will cause serious adverse health consequences or death.”
This medical device recall, the most serious recall category, was issued this February. The recall reportedly included 3,662 devices.
Risks included a need for revision surgery. According to experts, such surgeries might lead to permanent loss of shoulder function, infection and even death.”
Patients that may have received the Zimmer Biomet device may be entitled to compensation for their pain and/or suffering. For more information about filing a claim through Medical Claim Legal, complete a claim form at this link.