GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA device recall Z-1395-2023 · posted 2023-04-17 · Open, Classified
Recall details
- Recalling firm
- GRAMERCY EXTREMITY ORTHOPEDICS
- 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.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Open, Classified
- Product code
- HRS
- Quantity affected
- 24
- Distribution
- US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
- Date initiated
- 2023-04-04
- Date posted
- 2023-04-17
- Location
- Richardson, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEO 1st MTP Joint Arthrodesis Plating System (K200108) | Gramercy Extremity Orthopedics, LLC | 2020-03-26 |