Recall Z-0775-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-09-13, terminated 2020-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.. Reason: Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-13
- Terminated
- 2020-04-21
- Firm location
- Warsaw, IN, United States
Product description
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Reason for recall
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
Data sourced from openFDA. This site is unofficial and independent of the FDA.