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.
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Products
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
- Brand
- XTANT Medical
- UPC
- LOT: XS1920458A
Units Affected
4 units