BEUDAMED
    FDA Recall Terminated

    Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.

    Recall: Z-2602-2011 · Initiated May 10, 2011

    Recall

    Recall Number
    Z-2602-2011
    Event Number
    58763
    Firm
    Ortho Development Corporation
    FEI Number
    3017298928
    Product Code
    MBL
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 10, 2011
    Posted
    June 20, 2011
    Terminated
    November 9, 2011
    Address
    12187 South Business Park Dr, Draper, UT, 84020

    Description

    Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.

    Reason

    Tests on PVC packaging material resulted in alert levels for cytotoxicity.

    Action

    Ortho Development Corporation notified consignees by letter on May 11, 2011. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to return all remaining affected units to Ortho. Replacement product was to be shipped by May 31.

    Distribution

    Nationwide Distribution - USA including CA, FL, and TX.

    Quantity

    113 units