GRAMERCY EXTREMITY ORTHOPEDICS GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Brand
GRAMERCY EXTREMITY ORTHOPEDICS
Lot Codes / Batch Numbers
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)
Products Sold
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)
GRAMERCY EXTREMITY ORTHOPEDICS is recalling GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis due to 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 - 4. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 4/4/23, recall notices were mailed to customers and distributors who were asked to do the following: 1) Quarantine affected kits so they are ready for removal by the firm s sales reps or other contact. 2) If devices were transferred or further distributed, notify customers, or provide a customer list, so the recalling firm can notify these customers directly. 3) Complete and return the response form to msimpson@gramercyortho.com Customers with questions can contact the firm at 855-436-2278, 9AM 5PM, Monday - Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026