Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- Recall date
- June 10, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1961-2019
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- 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.
Why it was recalled
Lack of an adequate sterilization validation.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
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