Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Reported: July 24, 2019 Initiated: June 10, 2019 #Z-1961-2019
Product Description
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Reason for Recall
Lack of an adequate sterilization validation.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 1257
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510. Recalled by Zimmer Biomet, Inc.. Units affected: 1257.
Why was this product recalled? ▼
Lack of an adequate sterilization validation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1961-2019.
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