FDA Enforcement
Class II
Ongoing
Genesis Screw-In Anchor
Recall: Z-1168-2026
·
Reported February 4, 2026
Enforcement
- Recall Number
- Z-1168-2026
- Event ID
- 98312
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aju Pharm Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 4, 2026
- Initiation Date
- December 17, 2025
- Classification Date
- January 26, 2026
- Address
- Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, N/A, Korea (the Republic of)
Description
Genesis Screw-In Anchor
Reason
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Code Info
Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
Distribution
US Nationwide distribution in the states of CA & PR.
Quantity
600 units