Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA
Brand
Allez Spine, LLC
Lot Codes / Batch Numbers
Lot Numbers:10294-1, 10294-2, 10294-3, 10294-4 and 10294-5
Products Sold
Lot Numbers:10294-1,10294-2,10294-3,10294-4 and 10294-5
Allez Spine, LLC is recalling Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) due to 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 p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026