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U.S. Department of Health and Human Services

Class 2 Device Recall Novel VBR Spinal System

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  Class 2 Device Recall Novel VBR Spinal System see related information
Date Initiated by Firm August 16, 2007
Date Posted December 31, 2008
Recall Status1 Terminated 3 on January 12, 2009
Recall Number Z-0508-2009
Recall Event ID 48177
510(K)Number K050553  
Product Classification Spinal Vertebral Body Replacement Device - Product Code MQP
Product Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126.

Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
Code Information Lot Number: 611881
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
2051 Palomar Airport Rd Ste 100
Carlsbad CA 92011-1462
For Additional Information Contact Paula Morgan
760-431-9286 Ext. 6769
Manufacturer Reason
for Recall		 Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
FDA Determined
Cause 2		 Process control
Action The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.
Quantity in Commerce 4 units
Distribution Nationwide Distribution --- including states of AZ, FL, NY & TX.
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 = MQP and Original Applicant = ALPHATEC/NEXMED
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