Biomet, Inc. recalls BIOMET ZipTight

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

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0212-2026
• FDA 510(k) clearance · K130033The device's official FDA premarket clearance record
• FDA device classification · MBIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Biomet, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.