FDA Medical Device Recalls (openFDA)
Allez Spine, LLC: Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630
- Recall number
- Z-2063-2008
- Recalling firm
- Allez Spine, LLC
- Product
- Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630
- Status
- Terminated
- Initiated
- 2007-11-07
- Posted
- 2008-09-17
- Terminated
- 2010-01-19
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 4
- Distribution
- Nationwide to AZ, CA, CO & UT
- Lot, serial or model codes
- Catalog # LG-PR0630
- 510(k) numbers
- ["K050060","K051275"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3005032381
- Firm city
- Irvine
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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