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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Biomet
- Product type
- AC Joint Implant
- Model numbers
- UDI-DI 01)00880304478404(17)290130(10)0002587666, Lot Number 0002587666, 904834
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 23, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Confirm model 904834 and Lot 0002587666.
- 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.
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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.
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Safety Guide
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