7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Company
- Nuvasive Inc
- Recall Initiated
- January 5, 2009
- Posted
- November 19, 2012
- Terminated
- November 19, 2012
- Recall Number
- Z-0366-2013
- Quantity
- 240 units total
- Firm Location
- San Diego, CA
Reason for Recall
The tulip portion of the screw assembly can disengage from the shank after implantation.
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Lot / Code Info
Batch: JK2101, JK2163
Root Cause
Device Design
Action Taken
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.