Zimmer, Inc.: M/L Taper Hip Prosthesis Recalled for Size Labeling Errors

Agency Publication Date: September 7, 2023

Summary

Zimmer, Inc. is recalling 24 units of its M/L Taper Hip Prosthesis (Extended Offset, Reduced Neck Length) because of a labeling and manufacturing error. The size 4 implants are incorrectly etched and labeled as size 6, while the size 6 implants are etched and labeled as size 4. This swap means a surgeon might unintentionally attempt to implant the wrong sized component during a hip replacement surgery.

Risk

If a surgeon relies on the incorrect labeling or etching, they may select an implant that does not fit the patient's anatomy, which could lead to surgical delays, improper joint tension, or the need for a revision surgery to correct the sizing error.

What You Should Do

Identify if your implant is affected by checking the Item and Lot numbers on your medical records or packaging: M/L Taper Hip Prosthesis Size 4 (Item 00771100640, Lot 65236202) or Size 6 (Item 00771100440, Lot 65249215).
Confirm the Unique Device Identifier (UDI-DI) matches: 00889024131699 for Size 4 or 00889024131613 for Size 6.
If you are a patient who has recently undergone hip surgery using these components, contact your orthopedic surgeon or healthcare provider to discuss the status of your implant.
If you are a healthcare provider with these units in stock, immediately quarantine the affected lots and contact Zimmer, Inc. to arrange for their return.
Contact Zimmer, Inc. at their Warsaw, Indiana headquarters or through your local sales representative for more information regarding this voluntary recall.
For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Return

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

Affected Products

Product: M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4

Model / REF:

00771100640

UDI-DI: 00889024131699

Lot Numbers:

65236202

Product: M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 6

Model / REF:

00771100440

UDI-DI: 00889024131613

Lot Numbers:

65249215

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92889

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: Hospitals; Surgical Centers

Manufactured In: United States

Units Affected: 24 units

Distributed To: Alabama, California, Georgia, Michigan, New Jersey, Pennsylvania, Tennessee, Wisconsin

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

Identify if your implant is affected by checking the Item and Lot numbers on your medical records or packaging: M/L Taper Hip Prosthesis Size 4 (Item 00771100640, Lot 65236202) or Size 6 (Item 00771100440, Lot 65249215).

Confirm the Unique Device Identifier (UDI-DI) matches: 00889024131699 for Size 4 or 00889024131613 for Size 6.

If you are a patient who has recently undergone hip surgery using these components, contact your orthopedic surgeon or healthcare provider to discuss the status of your implant.

If you are a healthcare provider with these units in stock, immediately quarantine the affected lots and contact Zimmer, Inc. to arrange for their return.

Contact Zimmer, Inc. at their Warsaw, Indiana headquarters or through your local sales representative for more information regarding this voluntary recall.

For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.