FDAClass IIJanuary 18, 2017

Oxford Fixed Lateral Bearing recall: Labeling Error

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…

Why was Oxford Fixed Lateral Bearing 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Date of Mfg. 26 Apr 2015

Product
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…
Recalling firm
Zimmer Biomet, Inc.
Quantity
12 units distributed
Distribution
Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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