Recall Z-1395-2023 ยท HRS Plate, Fixation, Bone
GRAMERCY EXTREMITY ORTHOPEDICS
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
| Date | Apr 17, 2023 (initiated Apr 4, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 | 24 |
| Distribution | US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200108 | GEO 1st MTP Joint Arthrodesis Plating System Gramercy Extremity Orthopedics, LLC, Mar 26, 2020 |