BEUDAMED
    FDA Recall Terminated

    Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090, N1830R80-080, N1830R80-070, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, N182450-085, N182450-075, N182450-065, N182450-055, N182450-045. Retractor access system that allows placement of posterior spinal fixation implants.

    Recall: Z-1045-2013 · Initiated February 8, 2013

    Recall

    Recall Number
    Z-1045-2013
    Event Number
    64569
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    February 8, 2013
    Posted
    April 1, 2013
    Terminated
    December 9, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090, N1830R80-080, N1830R80-070, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, N182450-085, N182450-075, N182450-065, N182450-055, N182450-045. Retractor access system that allows placement of posterior spinal fixation implants.

    Reason

    Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may o

    Action

    Consignees were sent on 2/8/13 a Zimmer Spine "Urgent Medical Device Recall" letter dated February 08, 2013. The letter was sent to Surgeons and Facilities using the NexPosure MIS Access System. The letter described the product involved in the recall and the problem. Advised consignees to discontinue the use of the product and to contact their sales representative for removal. A consignee letter dated February 8, 2013 was also sent to Distributors, Sales Representatives, and Distribution Operation Managers Distributing the NexPosure MIS Access System. The letter contained instructions if they had the affected product or not and the steps to follow.

    Distribution

    Nationwide Distribution including the states of AZ, CO, DE, FL, ID, LMA, MI, NH, NJ, NM, PA, RI, TX, and VA.

    Quantity

    58