FDA Device

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

Hazard

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

What You Should Do

Remedy

On May 12, 2020 a customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to the three customers who received the affected devices. On May 19, 2020, an additional customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to one of the three affected customers.

Products

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Brand
XTANT Medical
UPC
LOT: XS1920458A

Units Affected

4 units