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U.S. Department of Health and Human Services

Class 2 Device Recall Novel Spinal Spacer System

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  Class 2 Device Recall Novel Spinal Spacer System see related information
Date Initiated by Firm May 13, 2009
Date Posted November 12, 2009
Recall Status1 Terminated 3 on November 13, 2009
Recall Number Z-0190-2010
Recall Event ID 52759
510(K)Number K080699  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124.

Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
Code Information Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
760-494-9286
Manufacturer Reason
for Recall		 Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
FDA Determined
Cause 2		 Process control
Action Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.
Quantity in Commerce 37 devices
Distribution Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
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 = MAX and Original Applicant = ALPHATEC SPINE, INC.
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