Device product
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0360-2013
Product summary
- Firm
- NuVasive Inc
- Event
- Event 52634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 units total
- Official record key
device-enforcement:Z-0360-2013
Official wording
Reason: The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information: Batch: JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, JK2244
Distribution pattern: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Derived failure modes
-
Unknown
The tulip portion of the screw assembly can disengage from the shank after implantation.