← FDA ENFORCEMENT
Z-1173-2026Class 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
416 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Product description
AlternatiV+ Screw-In Anchor
Code / lot info
Model No. 20BN4753, 20BN5503; All UDI Codes; All Lots.
Other recalls SPEQ maps to Documentation & Change Control
2026-10-21Class IIIn2bones USA, LLC2026-10-21Class IIW L Gore & Associates, Inc.2026-10-21Class IIEthicon, LLC2026-10-21Class IIBoston Scientific Corporation
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 →