BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0983-03 · Initiated June 26, 2003

    Recall

    Recall Number
    Z-0983-03
    Event Number
    26556
    Firm
    Numed Inc
    FEI Number
    1318694
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2003
    Posted
    July 8, 2003
    Terminated
    June 9, 2004
    Address
    2880 Main Street/Rt, 11b, Hopkinton, NY, 12965

    Description

    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.

    Reason

    Lacks a PMA or 510k.

    Action

    Recall Letters were sent to doctors dated 6/26/03 requesting return of the stents.

    Distribution

    The stents were shipped to individual doctors in 29 hospitals in the U.S.

    Quantity

    169 units