Class 2 Device Recall CP (Cheatham Platinum)

• Date Initiated by Firm: June 26, 2003
• Date Posted: July 08, 2003
• Recall Status: Terminated 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/ Manufacturer: Numed Inc; 2880 Main Street/Rt 11b; Hopkinton NY 12965
• For Additional Information Contact: Nichelle LaFlesh; 315-328-4491
• Manufacturer Reason for Recall: Lacks a PMA or 510k.
• FDA Determined Cause: Other
• 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.