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.
The company acknwledged that these shoulder trays, all manufactured prior to September 2011, would fracture easily.
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.