FDA recall Z-2500-2020
XTANT Medical · Class II · device
Product
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Reason for recall
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Distribution
AZ, TX and WV.
Key facts
- Status
- Terminated
- Initiation date
- 2020-05-12
- Report date
- 2020-07-15
- Termination date
- 2021-03-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Belgrade, MT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2500-2020