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U.S. Department of Health and Human Services

Class 2 Device Recall Trestle Anterior Cervical Plate

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  Class 2 Device Recall Trestle Anterior Cervical Plate see related information
Date Initiated by Firm August 25, 2009
Date Posted June 02, 2010
Recall Status1 Terminated 3 on June 07, 2010
Recall Number Z-1746-2010
Recall Event ID 55613
510(K)Number K070681  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008.

Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.
Code Information Lot Number: 5481103
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008
For Additional Information Contact
760-431-9286
Manufacturer Reason
for Recall		 The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant.
FDA Determined
Cause 2		 Labeling mix-ups
Action Alphatec Spine initiated a recall communication via telephone beginning August 25, 2009. Customers were given an explanation of the problem and instructed to check their inventory for the affected product. The firm indicated that they would arrange to have Federal Express contact customers for pick-up of the affected product(s) and replacement product would be sent out immediately. For further information, contact Alphatec Spine at 1-800-922-1356.
Quantity in Commerce 13 units
Distribution Nationwide Distribution -- AL, CA, FL, TN, TX and 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 = KWQ and Original Applicant = ALPHATEC SPINE, INC.
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