Zimmer Biomet Comprehensive Reverse Shoulder Recall
The FDA has recalled the Zimmer Biomet Comprehensive Reverse Shoulder System medical device.
The product is officially called the Comprehensive Reverse Shoulder System Humeral Tray, Model 115340. According to the manufacturer, it is “a shoulder replacement device that is surgically implanted to help restore arm movement.” It “is beneficial to patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.”
On December 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. This notice required customers to review the safety notice and ensure appropriate staff is aware of the notice, identify and quarantine any affected devices in stock, a sales representative from Zimmer Biomet will remove affected devices, complete the Certificate of Acknowledgement Form, and retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit.
The FDA recalled the device on February 11, 2017 due to a “higher than anticipated rate of fracturing due to design” and a “risk of revision surgery due to fracturing.” The FDA classifies this recall as a Class 1 recall stating that these revision surgeries could cause “serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.” The recall event ID is 75971. The recall is for 3,662 humeral trays (model 115340).
The FDA issued a Class 2 recall of the same device on June 17, 2013 because Biomet had “identified that the slot on the resection guide is offset in the wrong direction. When this happens, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.” A Class 2 recall is classified as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall terminated on June 9, 2014.
Taking both recalls into consideration there have been a total of 89 device problems reported. Nineteen of these problems are categorized under “No Information” followed by fifteen problems in both categories of “Dislodged or dislocated” and “Fracture.”
The device’s 501(K) number is K080642 and the 501(K) premarket notification decision was made on 03/06/2008. The device was distributed in the United States, Canada, Australia, Chile, Colombia, Korea, and The Netherlands. It was distributed between October 2008 and September 2015 and manufactured between August 25, 2008 and September 27, 2011.
A judgment was entered in Colorado last February for the amount of $350,000 against Biomet involving their Comprehensive Reverse Shoulder System. That action began July 30, 2014 and this particular plaintiff had devices implanted into both shoulders in 2009 and 2010, both failed.
If you or a loved one has been implanted with the Zimmer Biomet Comprehensive Reverse Shoulder System and had a revision surgery or other injury, contact the attorneys at Aylstock, Witkin, Kreis & Overholtz today. You may be entitled to financial compensation for your injuries.
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