Z-0155-2009

Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link...

Name: Z-0155-2009 Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link...
Creator: Allez Spine, LLC
Published: 2008-08-21
License: https://open.fda.gov/license/

Allez Spine, LLC / initiated 2008-08-21 / Terminated / root cause: manufacturing process

FDA source

Allez Spine, LLC began a recall of Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 Cross Link, Lange 50-80mm... on 2008-08-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0155-2009
Status: Terminated
Initiated: 2008-08-21
Posted: 2008-10-28
Terminated: 2010-01-19
Recalling firm: Allez Spine, LLC
Product: Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5mm
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA root cause: Pending
Action: 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.
Quantity in commerce: 6472 units for all systems
Distribution: Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
Product codes and lots: All Serial Numbers

Product code NKB

K070460Class IIAllez Spine Cross ConnectorsAllez Spine, LLC / cleared 2007-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)