The U.S. Food and Drug Administration (FDA) takes its consumer protection role very seriously. Every year, dozens of medical products that had once gained FDA approval are recalled due to unforeseen side effects or failures that cause consumers serious injury or death.
In mid-December of 2016, the FDA placed certain lot numbers of the the Zimmer Biomet Comprehensive Reverse Shoulder Humeral on recall. If you or a family member has been the recipient of a shoulder replacement procedure using this Biomet product, it is important to learn more about the recall.
The Nature Of The Problem
Per the FDA recall ruling, 3,662 of the implants used in surgeries between October of 2008 and September of 2015 have been found to fracture at a higher-than-demonstrated rate when the product originally received FDA approval in August of 2008. According to the FDA website, upon fracturing, patients frequently require revision/replacement surgery, which may ultimately result in total or partial loss of shoulder function, as well as infections at the surgical site. In rare instances, deaths have been reported as a complication of the revision surgeries.
Zimmer Biomet Has Complied With The Recall – But Liability Remains
Zimmer Biomet has fully complied with the FDA recall. The company has issued the required Urgent Medical Device Recall Notice and Certificate of Acknowledgement to all affected surgical facilities and patients receiving one of the recalled systems. Complying with the recall, however, does not relieve the manufacturer from liability for compensating injured parties for financial damages associated with the revision surgery and any medical complications that may result.
Talk To An Experienced Medical Malpractice Lawyer
If you or someone you know in Ohio has been medically harmed by the Biomet Comprehensive Reverse Shoulder Humeral, schedule a free consultation with a medical malpractice attorney at Colley Shroyer Abraham, in Columbus. We will review the circumstances of the case and discuss the medical and legal issues involved in helping you recover financial damages.