FDA recall Z-1167-2026

Product

Fixone Biocomposite Anchor

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA & PR.

Key facts

Status

Ongoing

Initiation date

2025-12-17

Report date

2026-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Seongnam, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2026