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Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Recalled July 24, 2019 · FDA recall Z-1961-2019 · Zimmer Biomet
Hazard
Lack of an adequate sterilization validation. · FDA Class II
Units
1257
Sold at
The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.
Description
Lack of an adequate sterilization validation.
Product
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →