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U.S. Department of Health and Human Services

Class 2 Device Recall CP (Cheatham Platinum)

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  Class 2 Device Recall CP (Cheatham Platinum) see related information
Date Initiated by Firm June 26, 2003
Date Posted July 08, 2003
Recall Status1 Terminated 3 on June 09, 2004
Recall Number Z-0983-03
Recall Event ID 26556
Product Classification Stent, Coronary - Product Code MAF
Product CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.
Code Information All lots produced.
Recalling Firm/
Numed Inc
2880 Main Street/Rt 11b
Hopkinton NY 12965
For Additional Information Contact Nichelle LaFlesh
Manufacturer Reason
for Recall
Lacks a PMA or 510k.
FDA Determined
Cause 2
Action Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.
Quantity in Commerce 169 units
Distribution The stents were shipped to individual doctors in 29 hospitals in the U.S.
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.