Oxford Fixed Lateral Bearing Size F Right recalled over labeling errors

Recall date

December 6, 2016

Source

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

Official notice title

Zimmer Biomet, Inc. recalls Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Alumin…

Recall number

Z-0956-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None

Why it was recalled

Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing.

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

What was recalled

Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement