Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Non-winged, Catalog # LG-P
FDA device recall Z-2068-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Allez Spine, LLC
- Reason for recall
- This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.
- Action taken
- Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory. All customers and consignees were contacted by the firm.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 9
- Distribution
- Nationwide to AZ, CA, CO & UT
- Date initiated
- 2007-11-07
- Date posted
- 2008-09-17
- Date terminated
- 2010-01-19
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM (K051275) | Allez Spine, LLC | 2005-12-09 |
| LAGUNA PEDICLE SCREW SYSTEM (K050060) | Allez Spine, LLC | 2005-05-04 |