Genesis Push-In Suture Anchor
FDA Recall #Z-1171-2026 — Class II — December 17, 2025
Product Description
Genesis Push-In Suture Anchor
Reason for Recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Recalling Firm
Aju Pharm Co., Ltd. — Seongnam, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
200 units
Distribution
US Nationwide distribution in the states of CA & PR.
Code Information
Model No. 10S30002; All UDI Codes; All Lots.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated