Roughly 3,662 of Warsaw, Ind.-based Zimmer-Biomet's Comprehensive Reverse Shoulder devices have been recalled, according to the FDA.
Here's what you need to know:
1. The FDA issued a Class I recall of the device on Dec. 15, 2016.
2. The product had been distributed between October 2008 and September 2015.
3. Surgically implanted in a patient's shoulder to restore arm movement, the Comprehensive Reverse Shoulder was designed treat patients suffering from rotator cuff tears and arthropathy.
4. Zimmer Biomet announced the devices fracture more often than stated in the labeling, leading to revision surgeries and loss of shoulder function, infection and death.
5. Healthcare providers and patients who received treatment using the device were sent a notice from the FDA informing them of the recall.
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