Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Num
FDA device recall Z-0190-2008 · posted 2008-03-11 · Terminated
Recall details
- Recalling firm
- Allez Spine, LLC
- Reason for recall
- Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.
- Action taken
- On July 30, 2007 Allez Spine notified all its field representatives and distributors via email of a potential for failure of the Size 8 Pedicle Screws when used in combination with the single piece locking nuts and instructed them to return all unused inventory of Size 8 Screws and the two piece Locking Nuts with saddle. This action was to be carried out to the retail level-hospital, clinic, lab, and physicians sold the product. The email also had an attachment of a list of expected frequently asked questions (FAQ) from surgeons and answers to help them respond. A second Notice to all users was sent by the recalling firm on Feb 29, 2008, to request follow-up of implanted units.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 305
- Distribution
- Nationwide: including the states of AZ, CA, CO, GA, NV, TX and UT
- Date initiated
- 2007-07-30
- Date posted
- 2008-03-11
- Date terminated
- 2012-04-09
- 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 PEDICLE SCREW SYSTEM (K050060) | Allez Spine, LLC | 2005-05-04 |