GEO Instrument Kit for EPS Plate — Class II medical device recall Z-1395-2023
Ongoing recall by GRAMERCY EXTREMITY ORTHOPEDICS, reported 2023-04-26, distributed nationwide. Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not t
| Recall number | Z-1395-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GRAMERCY EXTREMITY ORTHOPEDICS, Richardson, TX, United States |
| Recall initiated | 2023-04-04 |
| Classified | 2023-04-17 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 24 |
| Model numbers | 70120001 |
Product
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1395-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.