BEUDAMED
    FDA Recall Terminated

    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

    Recall: Z-0696-2020 · Initiated November 11, 2019

    Recall

    Recall Number
    Z-0696-2020
    Event Number
    84325
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    GFJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 11, 2019
    Terminated
    May 7, 2021
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

    Reason

    There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.

    Action

    The firm disseminated a medical device field correction notice on 11/11/2019 by letter. The letter explained the failure and requested the following actions be taken by hospital representatives: 1. Please check your inventory and complete the attached Inventory Correction Certification Form. 2. If you have the PROFIX 750 Gram Mallet, please maintain awareness of this notice. 3. When preparing for cleaning, disassemble the poly tip from the mallet and inspect disassembled components for damage or wear. 4. After cleaning, inspect disassembled components and ensure the components can be re-assembled securely. 5. Ensure the PROFIX 750 Gram Mallet is sterilized in the disassembled state. 6. After sterilization, ensure the poly tip is re-assembled to the mallet securely.

    Distribution

    Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela.

    Quantity

    1371 devices