GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
This recall is currently active, issued April 17, 2023. It was issued by Gramercy Extremity Orthopedics.
- Company
- Gramercy Extremity Orthopedics
- Recall Initiated
- April 4, 2023
- Posted
- April 17, 2023
- Recall Number
- Z-1395-2023
- Quantity
- 24
- Firm Location
- Richardson, TX
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
Lot / Code Info
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)
Root Cause
Mixed-up of materials/components
Action Taken
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.