FDA-Device2019-07-24Class II
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
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
1257
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1961-2019Don't want to check this manually?
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