FDA-Device2023-04-26Class II
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
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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