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GRAMERCY EXTREMITY ORTHOPEDICS recalls GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Recalled April 26, 2023 · FDA recall Z-1395-2023 · GRAMERCY EXTREMITY ORTHOPEDICS
Hazard
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. · FDA Class II
Units
24
Sold at
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
Description
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.
Product
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Manufacturer(s)
GRAMERCY EXTREMITY ORTHOPEDICS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →