Class IIReported 2026-02-04

Fixone Hybrid Anchor

Reason for Recall

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

Recall Number

Z-1166-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-17

Reported

2026-02-04

Distribution

US Nationwide distribution in the states of CA & PR.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.