Recall Z-1395-2023— GRAMERCY EXTREMITY ORTHOPEDICS
Class II · Ongoing
Class II FDA medical device recall by GRAMERCY EXTREMITY ORTHOPEDICS, initiated 2023-04-04. It names one FDA 510(k) clearance: K200108. Product: GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System. 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..
- Recalling firm
- GRAMERCY EXTREMITY ORTHOPEDICS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-04
- Firm location
- Richardson, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.