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U.S. Department of Health and Human Services

Class 1 Device Recall Blackstone Medical Inc.

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  Class 1 Device Recall Blackstone Medical Inc. see related information
Date Initiated by Firm December 23, 2005
Date Posted April 19, 2006
Recall Status1 Terminated 3 on April 09, 2013
Recall Number Z-0716-06
Recall Event ID 34355
510(K)Number K042514  
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product ICON Modular Spinal Fixation System used with the:
ICON Implant Case (containing Pedicle Screws) Item Number 54-1090
ICON Instrument Case 1 Item Number: 54-1091
ICON Instrument Case 2 Item Number: 54-1092
Code Information All lots
Recalling Firm/
Manufacturer		 Blackstone Medical Inc.
90 Brookdale Drive
Springfield MA 01104-3206
For Additional Information Contact Diane M Johnson
410-709-8276
Manufacturer Reason
for Recall		 Pedicle Screw may disengage in post op period requiring intervention
FDA Determined
Cause 2		 Device Design
Action Blackstone Medical notified Distributors by email on 12/23/05 to quarantine inventory. A letter notifying physicans was issued 12/28/05 via Fed''X. Product is to be returned to Blackstone Medical.
Quantity in Commerce 23 sets
Distribution AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany
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 = KWQ and Original Applicant = BLACKSTONE MEDICAL, INC.
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