Device product
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Z-1406-2022
Product summary
- Event
- Event 90537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 pieces
- Official record key
device-enforcement:Z-1406-2022
Official wording
Reason: Customized coronal rod benders may deform the implant when used with the spinal system devices.
Code information: LOT: 2930901A
Distribution pattern: United States: CO
Derived failure modes
-
Unknown
Customized coronal rod benders may deform the implant when used with the spinal system devices.