FDA-Device2023-04-26Class II
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
GRAMERCY EXTREMITY ORTHOPEDICS
Hazard
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.
Sold states
US Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.
Affected count
24
Manufactured in
1239 N Glenville Dr, N/A, Richardson, TX, United States
Products
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2023Don't want to check this manually?
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