Device product
6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Z-0373-2013
Product summary
- Firm
- NuVasive Inc
- Event
- Event 52634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 units total
- Official record key
device-enforcement:Z-0373-2013
Official wording
Reason: The tulip portion of the screw assembly can disengage from the shank after implantation.
Code information: Batch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173.
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.