FDA DevicesClass II
AlternatiV+ Screw-In Anchor
Published: February 4, 2026Recall ID: Z-1173-2026Category: devicesCountry: US
Reason for Recall / Hazard
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Product Description & Identification
AlternatiV+ Screw-In Anchor
Additional Source Details
| Field | Value |
|---|---|
| City | Seongnam |
| State | N/A |
| Event id | 98312 |
| Address 1 | Room 201, Room 207, Bl A |
| Address 2 | Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang |
| Code info | Model No. 20BN4753, 20BN5503; All UDI Codes; All Lots. |
| Postal code | N/A |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 416 units |
| Reason for recall | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251217 |
| Initial firm notification | Letter |
| Center classification date | 20260126 |
Overview
- Recalling FirmAju Pharm Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA & PR.