FDA recall Z-1395-2023

Product

GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Reason for recall

Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.

Distribution

US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.

Key facts

Status

Ongoing

Initiation date

2023-04-04

Report date

2023-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richardson, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2023