Z-0212-2026Class II

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

Name: Z-0212-2026 BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for...
Creator: Biomet, Inc.
Published: 2025-09-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2025-09-23 / Open, Classified

FDA source

Biomet, Inc. began a recall of BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair on 2025-09-23. FDA classified it as Class II and gives the reason as "There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0212-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-23
Posted: 2025-10-17
Recalling firm: Zimmer GmbH
Product: BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
FDA root cause: Under Investigation by firm
Action: 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 [email protected].
Quantity in commerce: 98 units
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.
Product codes and lots: UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0212-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0212-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-17

Product code MBI

K130033Class IIToggleloc Xtender; Toggleloc Xl; Implant Kit Toggleloc; Implant Kit Toggleloc Btb, Extended Toggleloc; Toggleloc; Btb toBiomet Manufacturing Corp / cleared 2013-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)