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Zimmer Biomet Reverse Shoulder Product Recall

Shoulder replacement surgeries are common and provide relief to thousands. But some conventional shoulder replacement surgeries don’t work, requiring a different type of shoulder replacement surgery.

In a typical shoulder replacement, artificial components replace natural ones, such that an artificial cup is placed into the shoulder while an artificial ball is placed at the top of the humerus, or arm bone. For individuals with rotator cuff tears and arthropathy, which is a complex type of shoulder arthritis, this type of shoulder replacement surgery doesn’t work.

Instead, patients must obtain a reverse shoulder replacement, which places the ball in the shoulder and the cup at the top of the humerus. One such reverse shoulder replacement medical device is Zimmer Biomet’s Comprehensive Reverse Shoulder System. However, this product has recently been recalled by Zimmer Biomet.

The Reverse Shoulder Recall

Zimmer Biomet Reverse Shoulder RecallOn December 15, 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder System, noting that it was fracturing far more often than expected and could lead to serious problems, such as infection, inability to use the shoulder and even death. Fracturing is an unusual problem, since most shoulder replacement complications do not involve fracturing, but instead deal with excessive wear, dislocating and loosening of joint components.

Due to the severity of the problem with the Comprehensive Reverse Shoulder System, the U.S. Food Drug and Administration (FDA) classified this recall as a Class I recall, which is the most serious type of recall available.

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