BEUDAMED
    FDA Recall Terminated

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    Recall: Z-1868-2017 · Initiated February 20, 2017

    Recall

    Recall Number
    Z-1868-2017
    Event Number
    76508
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    FEI Number
    3003714383
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2017
    Terminated
    September 18, 2017
    Address
    75 Queen St, Montreal Canada # 3300

    Description

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    Reason

    There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall - Lot Removal letter dated February 20, 2017, sent to the affected distributors and hospital Risk Managers and Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: This letter is initiating Phase I of the lot specific field removal of the iASSIST Validation Tool field removal. You are receiving this letter because our records indicate that you have received an affected product that needs to be corrected. Zimmer Biomet is currently making preparations for replacement activities to follow. This document is provided to alert all users of the potential issue and to highlight proper usage of the instrument per the existing surgical techniques in order to minimize the chance of any failure pending a replacement. A separate field removal notification will be issued with detailed instructions in April 2017. You will be notified when a replacement is available. Do not return any product at this time as a part of this field action. Your Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. The affected products can continue to be used until replacements are available. To minimize the chances of bending or breakage during use, please follow the iASSIST Knee Surgical Technique (Ref. 97-9001-101-00 Rev 9) and/or iASSIST Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2), specifically the following warning on pages 36 and 37, respectively. 3. Inspect affected devices before and immediately after use to confirm that the Drive Pins are not bent or broken. In case of breakage, the Drive Pin head will disassemble, as shown below. In the unlikely case of a breakage, make sure that both parts are retrieved from the wound. 4. Please keep Zimmer Biomet

    Distribution

    Nationwide Distribution

    Quantity

    84