FDA-Device2025-10-29Class II

BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

Biomet, Inc.
Hazard

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

Sold states
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.
Affected count
98 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0212-2026

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