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Recall Observatory FDA recall evidence

Device product

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

Z-1395-2023

April 04, 2023

Class II

Product summary

Firm
GRAMERCY EXTREMITY ORTHOPEDICS
Event
Event 92051
Status
Ongoing
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-1395-2023

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.