Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm;

FDA device recall Z-0155-2009 · 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

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