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U.S. Department of Health and Human Services

Class 2 Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)

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 Class 2 Recall
Ascent POCTS (Posterior Occipital Cervical Thoracic System)
see related information
Date Posted December 11, 2007
Recall Status1 Terminated on June 06, 2008
Recall Number Z-0363-2008
Recall Event ID 45523
Premarket Notification
510(K) Number
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
Code Information Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
Recalling Firm/
Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne, New Jersey 07470
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom
FDA Determined
Cause 2
Action Blackstone Medical, Inc., field representatives were notified via phone, e-mail or fax on 4/30/07. Attention: Notification of Product Removal Letters were sent on May 15, 2007, to distributors and implanting surgeons requesting return of non-implanted stock.
Quantity in Commerce 319 screws ( 212 domestic, 107 international)
Distribution Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
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.