Reported Apr 26, 2023 · Ongoing

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

Gramercy Extremity Orthopedics

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GRAMERCY EXTREMITY ORTHOPEDICS · 1239 N Glenville Dr · Richardson, TX · 75081-2412

Is this the product you have?

  • GEO Instrument Kit for EPS Plate
  • REF70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Lot codes and dates
  • 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)
    • 1022000283(10/13/27)
    • 1022000223(10/13/27)
    • 1022000363(10/13/27)
    • 1022000413(10/13/27)
    • 1022000453(10/13/27)
Amount recalled
24

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.