Aju Pharm Co., Ltd.: Medical Device Recall in 2026 - (Recall #: Z-1166-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Fixone Hybrid Anchor

Product Classification:

Class II

Date Initiated: December 17, 2025

Date Posted: February 4, 2026

Recall Number: Z-1166-2026

Event ID: 98312

Reason for Recall:

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Status: Ongoing

Product Quantity: 233 units

Code Information:

Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.

Distribution Pattern:

US Nationwide distribution in the states of CA & PR.

Voluntary or Mandated:

Voluntary: Firm initiated