FDAHealthSeptember 23, 2025
Biomet, Inc. — BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
⚠️ There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- September 23, 2025
Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA 2025-00166_Initial Distribution History containing the distribution and the identification of the domestic consignees.
What's affected?
- Product
- BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
- Brand
- Biomet, Inc.
- Lot code
- 0002587666
Additional details
UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 98 units.
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