Zimmer Z1 Femoral Hip System Recalled for Potential Tip Fracture

Agency Publication Date: March 24, 2025

Summary

Zimmer, Inc. has recalled 35 units of the Z1 Femoral Hip System due to a design issue with the Z1 Offset Stem Inserter. This tool, used during hip surgeries, is prone to fracturing at the distal tip. The recall affects Product Number 611777612 across six specific lot numbers.

Risk

If the inserter tip breaks during a surgical procedure, it could lead to surgical delays or fragments of the device being left inside the patient. This could potentially require additional surgery to remove the pieces. No injuries have been reported at this time.

What You Should Do

This recall involves the Z1 Femoral Hip System (Product Number 611777612) manufactured by Zimmer, Inc.
Surgical facilities and healthcare providers should check the lot numbers and UDI-DI (00887868577888) printed on the product labeling. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device. Contact Zimmer, Inc. or your distributor to arrange return, replacement, or correction.
Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Z1 Femoral Hip System

Model / REF:

611777612

Lot Numbers:

102646

102777

102778

104095

104324

105277

UDI:

00887868577888

Recall Number Z-1329-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96348

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: hospitals; surgical centers; medical distributors

Manufactured In: United States

Units Affected: 35 units

Distributed To: Nationwide

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.

What You Should Do

This recall involves the Z1 Femoral Hip System (Product Number 611777612) manufactured by Zimmer, Inc.

Surgical facilities and healthcare providers should check the lot numbers and UDI-DI (00887868577888) printed on the product labeling. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device. Contact Zimmer, Inc. or your distributor to arrange return, replacement, or correction.

Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.