BEUDAMED
    FDA Recall Terminated

    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

    Recall: Z-1123-2019 · Initiated September 21, 2018

    Recall

    Recall Number
    Z-1123-2019
    Event Number
    82379
    FEI Number
    1000116912
    Product Code
    KWZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 21, 2018
    Terminated
    September 16, 2020
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

    Reason

    Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery

    Action

    On 09/21/18, Urgent Field Safety Notices, updated surgical techniques, and Acknowledgement and Receipt Forms were emailed to Surgical Sales Agents. The Surgical Technique provides instructions on use of the manual T-handle as the primary tightening method. It also provides instructions for use of the torque wrench to ensure that the readout for the torque wrench is at "0" before torque is applied. Sales agents were asked to affirm that they have read and understood the updated Surgical Technique information provided in the Field Safety Notice Bulletin. They were also asked to affirm that they disseminated this information to all employed and contracted sales reps in their organization. On 01/29/19, Urgent Field Safety Notices were emailed to Surgical Agents. This notice communicated the exchange process for physical product in inventory. The firm will notify Surgical Agents to make arrangements for the exchange of affected inventory with proximal bodies that are packaged with new capture bolts containing a polyethene plug. Surgical Agents with additional questions were encouraged to call 512-834-6255.

    Distribution

    US: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, NV,.

    Quantity

    22