HIGH

Biomet ZipTight AC Joint Implant Recall for 98 Units Over Missing Slotted Button (2025)

Biomet recalled 98 ZipTight Acute AC Joint Implant Single Ziploop devices on Sept. 23, 2025. A missing slotted button assembly was identified in one lot. Healthcare providers and patients should stop using the device immediately and follow Biomet’s recall instructions.

Quick Facts at a Glance

Recall Date
September 23, 2025
Hazard Level
HIGH
Brand
Biomet
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL

Hazard Information

There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Biomet, Inc. or your healthcare provider for instructions

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About This Product

ZipTight AC Joint Implant, Single Ziploop is a surgical fixation system used in acromioclavicular joint repair.

Why This Is Dangerous

A missing slotted button assembly could compromise fixation, potentially requiring revision surgery.

Industry Context

This recall is not presented as part of a broader industry pattern.

Real-World Impact

The recall affects surgical implants and could delay treatment or require additional procedures if the device is used.

Practical Guidance

How to identify if yours is affected

  1. Confirm model 904834 and Lot 0002587666.
  2. Check packaging for UDI-DI 01)00880304478404(17)290130(10)0002587666.
  3. Refer to the recall notice for any additional identifiers.

Where to find product info

UDI-DI typically appears on packaging and labeling; Lot number 0002587666 is on the device labeling.

What timeline to expect

The recall notice does not specify a refund or replacement timeline.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or procurement.
  • File a report with FDA if device-related issues arise.
  • Document all communications and actions taken.

How to prevent similar issues

  • Verify recall status for implants before use.
  • Maintain updated supplier recalls in hospital risk management.
  • When purchasing implants, ensure traceability via UDI-DI and lot numbers.

Documentation advice

Keep the recall notice, device packaging, lot numbers, and all correspondence with Biomet and healthcare providers.

Product Details

Model/Catalog Number: 904834 UDI-DI: 01)00880304478404(17)290130(10)0002587666 Lot Number: 0002587666 Units recalled: 98 Recall date: 2025-09-23 Status: ACTIVE Distribution: Domestic consignees listed in ZFA 2025-00166 documents Sold/Used since: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 98 units recalled
  • Model 904834
  • Lot 0002587666
  • UDI-DI: 01)00880304478404(17)290130(10)0002587666
  • Recall date: 2025-09-23
  • Status: ACTIVE

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
UDI-DI 01)00880304478404(17)290130(10)0002587666
Lot Number 0002587666
904834
Report Date
October 29, 2025
Recall Status
ACTIVE

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