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U.S. Department of Health and Human Services

Class 2 Device Recall Ascent Posterior Occipital Cervical Thoracic System

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 Class 2 Recall
Ascent Posterior Occipital Cervical Thoracic System
see related information
Date Posted March 16, 2010
Recall Status1 Terminated on April 09, 2010
Recall Number Z-1144-2010
Recall Event ID 54507
Premarket Notification
510(K) Number
K030197 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.
Code Information Part Number: 65-2053, Lot Number: 047247.
Recalling Firm/
Manufacturer
Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne, New Jersey 07470
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Michael Romaniw
973-406-2812
Manufacturer Reason
for Recall
The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Orthofix Spinal Implants contacted customers by phone beginning December 22, 2009 and issued a Notification of Product Removal dated February 2, 2010. Consignees were instructed to Identify, Remove and Return all affected product to the firm. For further information, contact Orthofix Spinal Implants, Regulatory Affairs Department at 1-973-406-2812.
Quantity in Commerce 25
Distribution Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = BLACKSTONE MEDICAL, INC.
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