Device product
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Z-1405-2022
Product summary
- Event
- Event 90537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 pieces
- Official record key
device-enforcement:Z-1405-2022
Official wording
Reason: Customized coronal rod benders may deform the implant when used with the spinal system devices.
Code information: LOT: 2930902A
Distribution pattern: United States: CO
Derived failure modes
-
Unknown
Customized coronal rod benders may deform the implant when used with the spinal system devices.