FDA recall Z-0212-2026

Biomet, Inc. · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-09-23
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

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