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Aju Pharm Co., Ltd.: Fixone Hybrid Anchor

Medical DevicesSource: FDA (device) · Date: 2026-02-04

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Aju Pharm Co., Ltd.
Product
Fixone Hybrid Anchor
Reason / hazard
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA & PR.
Recall initiated
2025-12-17
Code info
Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.
Product quantity
233 units
Voluntary mandated
Voluntary: Firm initiated
City
Seongnam
State
N/A
Country
Korea (the Republic of)
Event id
98312
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