BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation ...
FDA Recall #Z-0212-2026 — Class II — September 23, 2025
Product Description
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Reason for Recall
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Recalling Firm
Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
98 units
Distribution
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.
Code Information
UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated