Zimmer Biomet Comprehensive Reverse Shoulder Humeral
On December 20, 2016 the medical device manufacturer Zimmer Biomet® sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected consumers notifying them of a Class I recall of their Comprehensive Reverse Shoulder Humeral® reverse shoulder replacement device. A Class 1 recall is the most serious type of recall, issued when use of a product could result in serious injuries or death.
Why Is The Comprehensive Reverse Shoulder Humeral Being Recalled?
The shoulder implant was distributed between October, 2008 and September, 2015 and affects nearly 4,000 patients. The device is surgically implanted to help restore arm movement in patients and is beneficial to patients who have suffered a rotator cuff tear or have developed a type of severe shoulder arthritis called arthropathy.
Zimmer Biomet was able to rush the device to market through the FDA's 501(k) fast-track approval process. This enabled to company to distribute the product without first conducting human trials. Zimmer Biomet is recalling the device due to device fractures at a higher rate than reasonably expected and as warned of on device labeling. Device fractures can lead to revision surgeries that may cause serious adverse health consequence to patients, such as permanent loss of shoulder function, infection, or even death.
How Our Attorneys Can Help
Strong Law Offices is currently investigating potential claims on behalf of individuals implanted with Zimmer Biomet's Comprehensive Reverse Shoulder Humeral system. If you or someone you know received a Zimmer Biomet Comprehensive Reverse Shoulder Humeral implant, you may be entitled to claim compensation for medical costs, lost income, pain and suffering, and other economic and noneconomic losses.
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Contact the experienced product liability lawyers at Strong Law Offices in Peoria by calling 1-800-234-0090 for a free consultation.