FDA-Device2019-11-13Class II
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
Zimmer Biomet, Inc.
Hazard
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Sold states
Distributed nationwide.
Affected count
5,459,583 total devices
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2020Don't want to check this manually?
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