Zimmer Biomet, Inc. recalls Comprehensive Mini Stem, Item No. 113631:
Recalled Product
Comprehensive Mini Stem, Item No. 113631:
Hazard / Issue
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Issued by
FDA
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