← FDA ENFORCEMENT
Z-1167-2026Class II

Aju Pharm Co., Ltd.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Aju Pharm Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2026-02-04
Distribution
US Nationwide distribution in the states of CA & PR.
Firm state
N/A
Product quantity
1,088 units
Initiated by
Voluntary: Firm initiated
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

Code / lot info

Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →