GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Recall Z-1395-2023 · Posted 2023-04-17
Recalling FirmGRAMERCY EXTREMITY ORTHOPEDICS
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2023-04-04
Product Quantity24
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.
Firm 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 [email protected]
Customers with questions can contact the firm at 855-436-2278, 9AM 5PM, Monday - Friday.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.