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U.S. Department of Health and Human Services

Class 2 Device Recall ICON

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  Class 2 Device Recall ICON see related information
Date Initiated by Firm May 21, 2009
Date Posted July 06, 2009
Recall Status1 Terminated 3 on April 07, 2015
Recall Number Z-1655-2009
Recall Event ID 52051
510(K)Number K042514  K083204  
Product Classification spinal implants - 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 NJ 07470
For Additional Information Contact SAME
413-731-8711
Manufacturer Reason
for Recall		 Product marketed without an approved 510(k)
FDA Determined
Cause 2		 Finished device change control
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 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.
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