Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Fem…

Recall date
April 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1741-2019
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS

Why it was recalled

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

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

What was recalled

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small

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