Aju Pharm Co., Ltd.: Device Recall

Recall #Z-1169-2026 · 12/17/2025

Class II: Risk

Recall Details

Recall Number: Z-1169-2026
Classification: Class II
Product Type: Device
Recalling Firm: Aju Pharm Co., Ltd.
Status: Ongoing
Date Initiated: 12/17/2025
Location: Seongnam, N/A, Korea (the Republic of)
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 400 units

Reason for Recall

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Product Description

Genesis Dual Thread Screw-In Anchor

Distribution Pattern

US Nationwide distribution in the states of CA & PR.

Other Recalls by Aju Pharm Co., Ltd.

Class II: Risk 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

View all recalls by Aju Pharm Co., Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.