Class 2 Device Recall BIOMET ZipTight

• Date Initiated by Firm: September 23, 2025
• Date Posted: October 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0212-2026
• Recall Event ID: 97670
• 510(K)Number: K130033
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
• Code Information: UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666
• FEI Number: 1825034
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer 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 Determined 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 CorporateQuality.PostMarket@zimmerbiomet.com.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MBI