Date Initiated by Firm |
February 02, 2010 |
Date Posted |
March 16, 2010 |
Recall Status1 |
Terminated 3 on April 09, 2010 |
Recall Number |
Z-1144-2010 |
Recall Event ID |
54507 |
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 NJ 07470
|
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 |
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
|
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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 = MNI and Original Applicant = BLACKSTONE MEDICAL, INC.
|