BEUDAMED
    FDA Recall Terminated

    Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA

    Recall: Z-2173-2010 · Initiated March 1, 2009

    Recall

    Recall Number
    Z-2173-2010
    Event Number
    55775
    Firm
    Sgarlato Med, LLC
    FEI Number
    2939320
    Product Code
    KWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 1, 2009
    Posted
    August 4, 2010
    Terminated
    August 19, 2011
    Address
    1975 Hamilton Ave, Ste 38, San Jose, CA, 95125-5630

    Description

    Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA

    Reason

    Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packages did not match.

    Action

    Recall initiated in March 2009 via telephone calls.

    Distribution

    Nationwide Distribution

    Quantity

    27 units