Screw-In Anchor Recall: Aju Pharm 10B45003-10B55003-10B65003
Announced 2026-02-04 · FDA
FDA is recalling Aju Pharm Co., Ltd.'s AlternatiV+ Screw-In Anchor due to reports of device failure including anchor breakage, bending, pull out, suture breakage, and secondary packaging breakage. Approximately 600 units were distributed nationwide in California and Puerto Rico. The recall covers Model Nos. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
| Brand | Aju Pharm Co., Ltd. |
|---|---|
| Product | Genesis Screw-In Anchor |
| Reason | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Severity | moderate |
| Units affected | 416 |
| Distribution | US Nationwide distribution in the states of CA & PR. |
| Agency | FDA |
| Recall / campaign no. | Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots. |
WHAT YOU SHOULD DO
- If you have this device implanted, contact your surgeon or medical provider immediately for evaluation.
- Do not attempt to remove or modify the device yourself; follow medical advice.
- Healthcare facilities with this device in inventory should quarantine units and await recall guidance from the manufacturer or FDA.
- Check for updates from the FDA or manufacturer for specific recall instructions and next steps.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.