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Zimmer Biomet, Inc. recalls Comprehensive Mini Stem, Item No. 113631:
Recalled December 19, 2018 · FDA recall Z-0591-2019 · Zimmer Biomet
Hazard
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. · FDA Class II
Units
3 total
Sold at
Distributed to accounts in IN, MD, MO, MS, and NM.
Description
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.
Product
Comprehensive Mini Stem, Item No. 113631:
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →