Recall Z-1960-2019— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-06-10, terminated 2020-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509. Reason: Lack of an adequate sterilization validation..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-10
- Terminated
- 2020-09-10
- Firm location
- Warsaw, IN, United States
Product description
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Reason for recall
Lack of an adequate sterilization validation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.