Aju Pharm Co., Ltd.: Device Recall

Recall #Z-1167-2026 · 12/17/2025

Class II: Risk

Recall Details

Recall Number: Z-1167-2026
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: 1,088 units

Reason for Recall

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

Product Description

Fixone Biocomposite 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.