FDA Medical devices recall ·
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model recall
- Recall number
- Z-0212-2026
- Date
- (initiated September 23, 2025)
- Company / brand
- Biomet, Inc.
56 E Bell Dr, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 98 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Why was it recalled?
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0212-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.