Class 2 Device Recall GEO Instrument Kit for EPS Plate

• Date Initiated by Firm: April 04, 2023
• Date Posted: April 17, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1395-2023
• Recall Event ID: 92051
• 510(K)Number: K200108
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
• 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)
• FEI Number: 3012478585
• Recalling Firm/ Manufacturer: GRAMERCY EXTREMITY ORTHOPEDICS; 1239 N Glenville Dr; Richardson TX 75081-2412
• For Additional Information Contact: 855-436-2278
• Manufacturer 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.
• FDA Determined Cause: Mixed-up of materials/components
• Action: 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.
• Quantity in Commerce: 24
• Distribution: US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HRS