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

Recall date

April 4, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1395-2023

FDA classification

Class II

Brand / firm

GRAMERCY EXTREMITY ORTHOPEDICS

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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