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U.S. Department of Health and Human Services

Class 2 Device Recall Codman

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  Class 2 Device Recall Codman see related information
Date Initiated by Firm March 21, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on February 17, 2016
Recall Number Z-2701-2011
Recall Event ID 58145
HDE Number H060001 
Product Classification Intracranial neurovascular stent - Product Code NJE
Product CODMAN ENTERPRISE¿ Vascular Reconstruction Device and Delivery System 4.5mm x 28mm
Product code: ENF452812
Code Information Lot Numbers:  01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796 
Recalling Firm/
Manufacturer
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact SAME
508-880-8100
Manufacturer Reason
for Recall
Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.
FDA Determined
Cause 2
Labeling design
Action Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011. The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman. Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative
Quantity in Commerce 380 units
Distribution Worldwide - Nationwide (USA), Canada, Korea.
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.
HDE Database HDEs with Product Code = NJE and Original Applicant = Medos International, SARL
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