Recall Z-1471-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-03-26, terminated 2020-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00. Reason: Potential failure of sterile packaging seal..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-26
- Terminated
- 2020-11-18
- Firm location
- Warsaw, IN, United States
Product description
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Reason for recall
Potential failure of sterile packaging seal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.