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
- 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
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.
at (432) 214-8125 or fill out our online form to schedule a case consultation
today. We look forward to speaking with you.