HIGH

Biomet Recalls AC Joint Implant Due to Missing Assembly Risk

Biomet recalled 98 units of its ZipTight Acute AC Joint Implant on September 23, 2025. The recall follows reports of a potential missing slotted button assembly in one lot. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 23, 2025
Hazard Level
HIGH
Brand
Biomet
Category
Health & Personal Care
Sold At
Multiple Retailers
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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Product Details

The recall affects the Biomet ZipTight Acute AC Joint Implant, Model/Catalog Number 904834. The affected lot number is 0002587666. These implants were distributed to multiple domestic consignees.

The Hazard

A missing slotted button assembly could compromise the device's effectiveness. This defect poses a high risk to patients receiving this implant.

Reported Incidents

No specific incidents have been reported. However, due to the potential malfunction, the risk of surgical complications is significant.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Biomet, Inc. or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0212-2026.

Key Facts

  • Recall date: September 23, 2025
  • Quantity recalled: 98 units
  • Classification: Class II
  • Risk level: High

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

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

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