Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GEO Instrument Kit for EPS Plate Recalled by GRAMERCY EXTREMITY ORTHOPEDICS Due to Instrument Kits for EPS plates may contain drill...

Date: April 4, 2023
Company: GRAMERCY EXTREMITY ORTHOPEDICS
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GRAMERCY EXTREMITY ORTHOPEDICS directly.

Affected Products

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

Quantity: 24

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GRAMERCY EXTREMITY ORTHOPEDICS

GRAMERCY EXTREMITY ORTHOPEDICS has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report