BEUDAMED
    FDA Recall Terminated

    Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

    Recall: Z-2126-2016 · Initiated November 25, 2015

    Recall

    Recall Number
    Z-2126-2016
    Event Number
    73198
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    MOQ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    November 25, 2015
    Terminated
    November 14, 2018
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

    Reason

    Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".

    Action

    DePuy Synthes sent an Urgent Notice Recall Notification dated November 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to review their inventory and immediately remove any affected devices, complete the verification section of the letter and return it to the Anspach Effort Inc., and return any affected product to their DePuy Synthes Sales Consultant. Any questions regarding this recall / removal contact the Complain Handling Unit Manager at (561) 494-3673 or their DePuy Synthes Sales Consultant. For further questions regarding this, please call (561) 627-1080.

    Distribution

    US Distribution to the state of : VA and Internationally to: Thailand and UK

    Quantity

    20 hand pieces