Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400…

Recall date
October 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0322-2020
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Distributed nationwide.

Why it was recalled

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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