BEUDAMED
    FDA Recall Terminated

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    Recall: Z-2732-2014 · Initiated August 15, 2014

    Recall

    Recall Number
    Z-2732-2014
    Event Number
    69132
    Firm
    Apollo Endosurgery Inc
    FEI Number
    3006722112
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    August 15, 2014
    Posted
    September 30, 2014
    Terminated
    February 1, 2016
    Address
    1120 S Capital Of Texas Hwy, Bldg. 1 Ste. 300, West Lake Hills, TX, 78746-6464

    Description

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    Reason

    Product was distributed past its expiration date.

    Action

    Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted.

    Distribution

    Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.

    Quantity

    10