Medical device manufacturer Zimmer Biomet has recalled its Comprehensive Reverse Shoulder implant. The device was intended for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and had a previously failed shoulder joint replacement.
The Comprehensive Reverse Shoulder is being recalled because the devices are fracturing at a higher rate than is stated in the product’s labeling. Device fractures may result in the need for revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or death.
This is a Class I recall; the most serious recall type. Class I recalls are made when there is a risk of serious injury or death.
The recalled devices were manufactured from August 2008 through September 2011 and were distributed as late as September 2015. It is believed that approximately 3,600 devices are subject to the recall.
Consumers may report any problems they experienced with the Comprehensive Reverse Shoulder device to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by fax to 1-800-FDA-0178.