FDA Device recall Z-1167-2026
Fixone Biocomposite Anchor
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Fixone Biocomposite Anchor by Aju Pharm, citing reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1167-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-17 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Aju Pharm |
| Distribution | US |
Product
Fixone Biocomposite Anchor
Reason
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Identifiers
| code_info | Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1167-2026%22
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