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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Biomet ZipTight AC Joint Implants Recalled for Missing Button Assembly

Agency Publication Date: October 17, 2025
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Summary

Biomet, Inc. is recalling 98 units of the BIOMET ZipTight Acute AC Joint Implant (Single Ziploop, Model/Catalog Number 904834). The recall was initiated because a specific lot may be missing a slotted button assembly, which is an essential part of the fixation system used for AC joint repair. Healthcare facilities should immediately stop using these implants and contact the manufacturer or their distributor for instructions.

Risk

If the slotted button assembly is missing, the implant cannot properly secure the joint, which may lead to surgical delays, the need for alternative devices during a procedure, or potential failure of the joint repair if the defect is not caught before implantation.

What You Should Do

  1. This recall affects the BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop (Model/Catalog Number 904834) with Lot Number 0002587666.
  2. Identify the affected product by checking the lot number and UDI-DI (01)00880304478404 on the device packaging.
  3. Stop using the recalled device immediately and quarantine any unused inventory matching the affected lot.
  4. Contact Biomet, Inc. or your distributor to arrange for the return, replacement, or correction of the recalled implants.
  5. If you are a patient who has recently undergone AC joint repair and have concerns about your implant, contact your healthcare provider or surgeon.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop
Model / REF:
904834
Lot Numbers:
0002587666
UDI:
00880304478404

Fixation System for AC Joint Repair; Recall #: Z-0212-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97670
Status: Active
Manufacturer: Biomet, Inc.
Sold By: Medical distributors; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 98 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 ยท 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.