Recall Z-0212-2026— Biomet, Inc.

Name: FDA recall Z-0212-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-23

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2025-09-23. It names one FDA 510(k) clearance: K130033. Product: BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K130033 — TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TOBiomet Manufacturing Corp·cleared 2013-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.