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U.S. Department of Health and Human Services

Class 2 Device Recall Zodiac Polyaxial Spinal Fixation System

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 Class 2 Device Recall Zodiac Polyaxial Spinal Fixation Systemsee related information
Date Initiated by FirmNovember 03, 2008
Date PostedDecember 07, 2009
Recall Status1 Terminated 3 on December 08, 2009
Recall NumberZ-0491-2010
Recall Event ID 50685
510(K)NumberK042673 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductZodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
Code Information Part Number: 62665-50 Lot Number: 617945
FEI Number 2027467
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
2051 Palomar Airport Rd Ste 100
Carlsbad CA 92011-1462
For Additional Information Contact
760-431-9286
Manufacturer Reason
for Recall		Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
FDA Determined
Cause 2		Error in labeling
ActionAlphatec Spine contacted consignees via phone on October 16, 2008 and requested that consignees immediately remove the Zodiac Titanium cannulated polyaxial screws (6.5 mm x 50 mm L) from the surgical set to help ensure that they will not be used in surgery. There is a script the company developed to assure consistent responses to customers, and a phone number for more information. The strategy calls for products to be returned to Alphatec Spine. The company will arrange to have Federal Express contact the consignees for pick-up of the screws. Follow up questions are directed to the company at 1-800-922-1356.
Quantity in Commerce56
DistributionAZ, CA, FL, TX
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 = KWP
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