The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1395-2023·Announced 2023-04-26

Instrument Kit Drill Guides Have Incorrect Depth Range

GEO Instrument Kits for EPS Plates contain drill guides marked with an incorrect depth range (30mm-60mm instead of 10mm-40mm), which could affect surgical implant placement.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving surgical instruments with mislabeled specifications. While no injuries or illnesses have been reported, this represents a risk-of-harm product where incorrect drill depth could lead to improper surgical technique and compromised implant placement.

Plain-English summary

GRAMERCY EXTREMITY ORTHOPEDICS is recalling the GEO Instrument Kit for EPS Plates (REF: 70120001), part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System. The drill guides in affected kits are marked with an incorrect drill depth range of 30mm-60mm; the correct range is 10mm-40mm.

Drill depth specifications are critical for proper surgical technique. Using the incorrect depth range during arthrodesis procedures could result in improper implant placement and compromise surgical outcomes.

Twenty-four units with this defect have been distributed in Connecticut, Oregon, New Jersey, Arizona, and Ohio. Healthcare facilities and surgical centers in these states that received affected kits should verify their inventory against the listed serial numbers (1022000493, 1022000623, 1022000683, and others through 1022000453) with expiration date 10/13/27.

Do not use affected instrument kits in surgical procedures. Contact GRAMERCY EXTREMITY ORTHOPEDICS immediately for replacement kits or return instructions if your facility has units matching the recalled serial numbers.

The recalled product

Product
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Manufacturer
GRAMERCY EXTREMITY ORTHOPEDICS
Category
Medical Device — Surgical Instrument Kit
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI B471701200010
  • Serial Number(Expiration Date): 1022000493(10/13/27)
  • 1022000623(10/13/27)
  • 1022000683(10/13/27)
  • 1022000243(10/13/27
  • 1022000313(10/13/27)
  • 1022000913(10/13/27)
  • 1022001213(10/13/27)
  • 1022000403(10/13/27)
  • 1022000383(10/13/27)
  • 1022000883(10/13/27)
  • 1022000353(10/13/27)
  • 1022000663(10/13/27)
  • 1022000733(10/13/27)
  • 1022000793(10/13/27)
  • 1022000983(10/13/27)
  • 1022000993(10/13/27)
  • 1022000373(10/13/27)
  • 1022001193(10/13/27)
  • 1022000523(10/13/27)

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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