FDA recall Z-2971-2026

Product

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

Reason for recall

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Distribution

US Nationwide distribution i the state of MT.

Key facts

Status

Ongoing

Initiation date

2026-07-10

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2971-2026