Recall Z-0322-2020— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-10-10, terminated 2020-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148. Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-10
- Terminated
- 2020-05-19
- Firm location
- Warsaw, IN, United States
Product description
Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Data sourced from openFDA. This site is unofficial and independent of the FDA.