FDA Medical Device Recalls (openFDA)
NuVasive Inc: 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Recall number
- Z-0355-2013
- Recalling firm
- NuVasive Inc
- Product
- 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Status
- Terminated
- Initiated
- 2009-01-05
- Posted
- 2012-11-19
- Terminated
- 2012-11-19
- Reason
- The tulip portion of the screw assembly can disengage from the shank after implantation.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 240 units total
- Distribution
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- Lot, serial or model codes
- Batch: JK2057, JK2157.
- 510(k) numbers
- ["K082332"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3002980729
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28