High Fracture Rate – Zimmer Biomet Shoulder Replacement Device

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.  

Risks include:

  • Death
  • Infection
  • 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.

Zimmer Biomet Receives FDA Class I Recall for Shoulder Device

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 BiometZimmer 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.

Zimmer Biomet
Notice that risk managers received related to Zimmer Biomet recall.

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.