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U.S. Department of Health and Human Services

Class 2 Device Recall Allez Spine Cross Connectors

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 Class 2 Device Recall Allez Spine Cross Connectorssee related information
Date Initiated by FirmAugust 21, 2008
Date PostedOctober 28, 2008
Recall Status1 Terminated 3 on January 19, 2010
Recall NumberZ-0155-2009
Recall Event ID 49444
510(K)NumberK070460 
Product Classification Spinal Pedicle Fixation - Product Code NKB
ProductAllez 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
Code Information All Serial Numbers 
FEI Number 3005032381
Recalling Firm/
Manufacturer		 Allez Spine, LLC
2301 Dupont Dr Ste 510
Irvine CA 92612-7518
For Additional Information ContactMark De Baca
800-939-7008
Manufacturer 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.
FDA Determined
Cause 2		Pending
ActionAllez 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 Commerce6472 units for all systems
DistributionNationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NKB
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