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(10/13/271022000313(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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