Zimmer Biomet (formerly “Zimmer”) is adding shoulder implants to its list of recalled joint replacements. In December 2016, the company issued an Urgent Medical Device Recall Notice to all affected medical providers, directing them to review the notice with necessary staff and to quarantine all remaining devices in their stock. The recall covers 3,662 devices.
Zimmer Biomet Comprehensive Reverse Shoulder
The Zimmer Biomet Comprehensive Reverse Shoulder is primarily used as treatment for patients with torn rotator cuffs who have not found success with shoulder repair surgery. The implant is intended to restore range of motion in the shoulder which is lost with a rotator cuff injury.
The devices, however, have a high fracture rate which causes patients to require revision surgeries. These additional surgeries can have catastrophic consequences, including increased or total loss of shoulder function, infection, and in some cases, death.
FDA Labels Recall Class 1
The United States Food and Drug Administration (FDA) has identified this recall as Class 1. The FDA website calls Class 1, “the most serious type of recall.” The FDA is requiring that all remaining devices be removed from medical facilities by Zimmer Biomet representatives. The FDA has not offered any advice or instruction regarding patients who have already received the implant, other than to following normal surgical protocol should an implanted device require revision.
New Jersey and Philadelphia Personal Injury Attorneys
The Philadelphia personal injury attorneys at Messa & Associates are experienced with cases involving defective products. If you or a loved one has been injured by a defective or faulty product, contact the Philadelphia personal injury attorneys at Messa & Associates, P.C. for a free consultation by calling 877-MessaLaw. You can also submit an inquiry online for a free case evaluation. Let Messa & Associates earn you the compensation you deserve.