Z-1395-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- April 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
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.
Distribution Pattern
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
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)