FDAClass IIDecember 27, 2023

Biolox Ceramic Option Head Zimmer 12/14 40mm -3 recall

Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

Why was Biolox Ceramic Option Head Zimmer 12/14 40mm -3 recalled?

One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: 00889024430556; Lot Number: 3145299

Product
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Recalling firm
Biomet, Inc.
Quantity
10 units
Distribution
US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
Recall date
December 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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