Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 0045000…

Recall date
October 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0306-2020
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

TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600

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