Biomet, Inc. recalls Comprehensive Humeral Tray Taper Extraction Pliers - Replace
Recalled Product
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Hazard / Issue
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Issued by
FDA
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