← FDA ENFORCEMENT
Z-0212-2026Class II

Biomet, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Biomet, Inc.
Product type
Device
Status
Ongoing
Report date
2025-10-29
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.
Firm state
IN
Product quantity
98 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →