Biomet Shoulder Recall: What You Should Know
By: Dean Law Firm
The Biomet Comprehensive Reverse Shoulder Humeral Tray is a shoulder replacement device doctors can surgically implant into your shoulder to help restore arm movement. The product is often used for people who have torn their rotator cuffs or developed severe arthropathy (shoulder arthritis). However, just last December, the device was recalled by its manufacturer, Zimmer Biomet, Inc., after the Food and Drugs Administration (FDA) discovered it qualifies as a Class 1 recall, one of the most dangerous kinds of product recalls.
Zimmer Bioment, Inc. recalled units on December 15, 2016, because the devices were found to fracture at a higher rate than was stated in the labeling. These fractured devices could cause serious adverse health consequences, such as permanent loss of shoulder function, infection, or even death.
One study in the Journal of Bone & Joint Surgery found patients with a higher body mass index (BMI) were likely to also require revision shoulder surgery after using a Biomet shoulder implant. Complication also increased with increased BMI, most likely because of the increased pressure of the body on the implant.
The notice of recall has affected about 3,662 Biomet Trays, including the following:
- Those manufactured from August 25, 2008, to September 27, 2011
- Those distributed from October 2008 to September 2015
- Product codes: KWS, PAO
- All lots with part number 115340
For more information about the specific codes affected, visit the FDA’s website regarding the recall here. If you’ve already been injured by the device, you might be able to take legal action. The Dean Law Firm can offer you a number of dedicated and skilled Midland personal injury attorneys. Our firm is dedicated to representing the victims of negligence and carelessness and helping them get the compensation they deserve. If your medical bills are overwhelming you as a result of a defective medical device, hold the manufacturer accountable. Our firm can offer you client-centered services and a record of numerous case successes. Let us see how we can help you.
Contact us at (281)280-8900 or fill out our online form to schedule a case consultation today. We look forward to speaking with you.