Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Recall date
October 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0594-2020
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

Why it was recalled

Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

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 Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

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