Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw System Tray #1; IT-FN 1002 Lagu
FDA device recall Z-0154-2009 · posted 2008-10-28 · Terminated
Recall details
- Recalling firm
- Allez Spine, LLC
- Reason for recall
- This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.
- Action taken
- Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.
- Root cause
- Pending
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 6472 units for all systems
- Distribution
- Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
- Date initiated
- 2008-08-21
- Date posted
- 2008-10-28
- 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 |