CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report
GEO Instrument Kit for EPS Plate recalled
Gramercy Extremity Orthopedics is recalling GEO Instrument Kit for EPS Plate, distributed nationwide in the US. The recall was initiated on 4 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1395-2023
- FDA event ID
- 92051
- Recalling firm
- Gramercy Extremity Orthopedics, Richardson, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Apr 2023
- FDA classified
- 17 Apr 2023
- Reported
- 26 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Apr 2023 | Recall initiated by company | |
| 17 Apr 2023 | Classified by FDA | +13 days |
| 26 Apr 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Where it was distributed
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
Questions about this recall
Why was it 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.
Which lots are affected?
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)
Where was it sold?
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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