CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
ZipTight, Acute AC Joint Implant, Single Ziploop recalled by Biomet
Biomet is recalling ZipTight, Acute AC Joint Implant, Single Ziploop. The recall was initiated on 23 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0212-2026
- FDA event ID
- 97670
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Sep 2025
- FDA classified
- 17 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Sep 2025 | Recall initiated by company | |
| 17 Oct 2025 | Classified by FDA | +24 days |
| 29 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Product as listed by the FDA
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Where it was distributed
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.
Questions about this recall
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
Which lots are affected?
UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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