Orthopedic Salvage System 9cm prosthesis recalled over labeling errors

Recall date

December 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Ti…

Recall number

Z-1114-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

WI NJ CA MD WA LA MA TX

Why it was recalled

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

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) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies