FDA-Device2019-07-24Class II
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Zimmer Biomet, Inc.
Hazard
Lack of an adequate sterilization validation.
Sold states
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.
Affected count
92
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1960-2019Don't want to check this manually?
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