BEUDAMED
    FDA Recall Terminated

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    Recall: Z-2548-2018 · Initiated April 28, 2010

    Recall

    Recall Number
    Z-2548-2018
    Event Number
    80415
    Firm
    Cayenne Medical Inc.
    FEI Number
    3006108336
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 28, 2010
    Terminated
    February 26, 2019
    Address
    16597 N 92nd St, Ste 101, Scottsdale, AZ, 85260-1847

    Description

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    Reason

    A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

    Action

    Customers were contacted via email on approximately 10/10/2013 and were instructed to return any affected products on hand.

    Distribution

    Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.

    Quantity

    1,444 units total