GRAMERCY EXTREMITY ORTHOPEDICS: Medical Device Recall in 2023 - (Recall #: Z-1395-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 4, 2023

Date Posted: April 26, 2023

Recall Number: Z-1395-2023

Event ID: 92051

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 24

Code Information:

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated