FDA Enforcement
Class II
Terminated
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Recall: Z-0369-2013
·
Reported November 28, 2012
Enforcement
- Recall Number
- Z-0369-2013
- Event ID
- 52634
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- NuVasive Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 28, 2012
- Initiation Date
- January 5, 2009
- Classification Date
- November 19, 2012
- Termination Date
- November 19, 2012
- Address
- 7475 Lusk Blvd, N/A, San Diego, CA, 92121-5707, United States
Description
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Reason
The tulip portion of the screw assembly can disengage from the shank after implantation.
Code Info
Batch: JK2036, JK2132, JK2350.
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Quantity
240 units total