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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 Connectors see related information
Date Initiated by Firm August 21, 2008
Date Posted October 28, 2008
Recall Status1 Terminated 3 on January 19, 2010
Recall Number Z-0155-2009
Recall Event ID 49444
510(K)Number K070460  
Product Classification Spinal Pedicle Fixation - Product Code NKB
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
Code Information All Serial Numbers 
Recalling Firm/
Manufacturer		 Allez Spine, LLC
2301 Dupont Dr Ste 510
Irvine CA 92612-7518
For Additional Information Contact Mark 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NKB and Original Applicant = ALLEZ SPINE, LLC
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