—#216290

Product

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

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K130033
Affected lot / code info: UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Zimmer Biomet issued an URGENT MEDICAL DEVICE RECALL notice to its consignees (Distributors and Risk Managers-separate notices) on 09/23/2025 via FedEx 2nd day. The notice explained the issue, risk, and requested the consignee (distributors) identify and quarantine the affected product and immediately return all affected product from your distributorship and from affected hospitals within your territory, review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall, Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format, and If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. Risk Managers were requested to quarantine all affected product pending collection from the distributor, and to provide a copy of the notice to those to whom the product was distributed. For questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-09-23
Posted by FDA: 2025-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.