BEUDAMED
    FDA Recall Terminated

    Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscopic Linear Cutter, product code i45; Intelligent 45mm Articulating Endoscopic Linear Cutter, Vascular, product code i45V.

    Recall: Z-0408-2010 · Initiated September 23, 2009

    Recall

    Recall Number
    Z-0408-2010
    Event Number
    53694
    Firm
    Surgical Devices/Covidien
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 23, 2009
    Posted
    November 23, 2009
    Terminated
    March 8, 2010
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscopic Linear Cutter, product code i45; Intelligent 45mm Articulating Endoscopic Linear Cutter, Vascular, product code i45V.

    Reason

    Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

    Action

    The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.

    Distribution

    The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.

    Quantity

    285 units