Genesis Knotless Anchor
FDA Recall #Z-1170-2026 — Class II — December 17, 2025
Product Description
Genesis Knotless 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
1,163 units
Distribution
US Nationwide distribution in the states of CA & PR.
Code Information
Model No. 10KPN4751, 10KPN5501; All UDI Codes; All Lots.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated