Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811

Recall date
July 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2232-2019
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.

Why it was recalled

Cleaning processes potentially being ineffective

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

What was recalled

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811

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