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U.S. Department of Health and Human Services

Class 2 Device Recall GEO Instrument Kit for EPS Plate

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  Class 2 Device Recall GEO Instrument Kit for EPS Plate see related information
Date Initiated by Firm April 04, 2023
Date Posted April 17, 2023
Recall Status1 Open3, 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)
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 2		 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 and Original Applicant = Gramercy Extremity Orthopedics, LLC
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