FDA-Device2020-07-15Class II

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

XTANT Medical
Hazard

The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.

Sold states
AZ, TX and WV.
Affected count
4 units
Manufactured in
664 Cruiser Ln, Belgrade, MT, United States
Products
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2500-2020

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