Biomet, Inc.: Biolox Ceramic Option Heads Recalled Due to Incorrect Packaging and Sizing

Agency Publication Date: December 18, 2023

Summary

Biomet, Inc. is recalling 20 units of Biolox Ceramic Option Heads because some packages contained an incorrect adapter size. Specifically, an adapter with a neck length of M/+0 was found inside packaging that should have contained a size S/-3.0 adapter. This defect was discovered through a product complaint and affects items distributed in several U.S. states and the Netherlands. The difference in size can be identified by looking for the 'S' or 'M' size indicator printed directly on the device.

Risk

Using the incorrect adapter size during surgery can lead to improper joint tensioning and hip instability, potentially requiring a follow-up surgery to correct the alignment. One complaint has been received regarding this packaging error, though no specific injuries were mentioned.

What You Should Do

Check your surgical inventory for Biolox Ceramic Option Head Zimmer 12/14 40mm -3 (Item Number 00-8777-040-01) with Lot Number 3145299 and UDI-DI 00889024430556.
Check your surgical inventory for Biolox Ceramic Option Head Zimmer 12/14 40mm +0 (Item Number 00-8777-040-02) with Lot Number 3145300 and UDI-DI 00889024430563.
Inspect the physical device for the size indicator; verify if the size (S or M) marked on the adapter matches the size indicated on the external product packaging.
Immediately stop using any affected products from these specific lots and set them aside to prevent use in surgical procedures.
Contact your healthcare provider or Biomet, Inc. (Zimmer Biomet) at their Warsaw, Indiana facility for further instructions on returning the affected devices and obtaining replacements.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

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

Model / REF:

00-8777-040-01

Z-0569-2024

UPC Codes:

00889024430556

Lot Numbers:

3145299

Product: Biolox Ceramic Option Head Zimmer 12/14 40mm +0

Model / REF:

00-8777-040-02

Z-0570-2024

UPC Codes:

00889024430563

Lot Numbers:

3145300

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93486

Status: Active

Manufacturer: Biomet, Inc.

Sold By: Authorized Medical Distributors

Manufactured In: United States

Units Affected: 2 products (10 units)

Distributed To: Alabama, California, Maryland, Michigan, North Carolina, Ohio, Oklahoma, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your surgical inventory for Biolox Ceramic Option Head Zimmer 12/14 40mm -3 (Item Number 00-8777-040-01) with Lot Number 3145299 and UDI-DI 00889024430556.

Check your surgical inventory for Biolox Ceramic Option Head Zimmer 12/14 40mm +0 (Item Number 00-8777-040-02) with Lot Number 3145300 and UDI-DI 00889024430563.

Inspect the physical device for the size indicator; verify if the size (S or M) marked on the adapter matches the size indicated on the external product packaging.

Immediately stop using any affected products from these specific lots and set them aside to prevent use in surgical procedures.

Contact your healthcare provider or Biomet, Inc. (Zimmer Biomet) at their Warsaw, Indiana facility for further instructions on returning the affected devices and obtaining replacements.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.