MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramComprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture RateAUDIENCE: Risk Manager, Orthopedics ISSUE: Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. BACKGROUND: The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement. RECOMMENDATION: On December 20, 2016 Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice asked customers to:
The notice also stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the Recall Notice, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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