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U.S. Department of Health and Human Services

Class 2 Device Recall ICON

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 Class 2 Recall
ICON
see related information
Date Posted July 06, 2009
Recall Status1 Open
Recall Number Z-1655-2009
Recall Event ID 52051
Premarket Notification
510(K) Number
K042514 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
Code Information All lots
Recalling Firm/
Manufacturer
Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne, New Jersey 07470
For Additional Information Contact SAME
413-731-8711
Manufacturer Reason
for Recall
Product marketed without an approved 510(k)
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Blackstone issued the recall notice to distributors by FedEx and email on May 21, 2009. This notification provides instructions to the field representatives how to return the product to Blackstone Medical. The Dear Doctor (Surgeon) letters are being sent Tues, May 26, 2009.
Quantity in Commerce 63 implant kits, 80 instrument kits
Distribution Nationwide
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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