BEUDAMED
    FDA Recall Terminated

    Universal Battery Charger II (UBC II)

    Recall: Z-1994-2016 · Initiated January 15, 2016

    Recall

    Recall Number
    Z-1994-2016
    Event Number
    73203
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    MOQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 15, 2016
    Terminated
    December 14, 2016
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    Universal Battery Charger II (UBC II)

    Reason

    The device is reported to enter safe mode and is no longer able to charge batteries.

    Action

    DePuy Synthes sent an "Urgent Notice- Medical Device Recall (Removal) letter dated January 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informing them of the recall (removal) and asking them to return the UBC II when it display the blue flashing lights that indicate service and to contact DePuy Synthes Customer Support at 800-327-6887 option 2 for return device and arrange to repair or replacement. Any other question please contact the Complaint Handling Unit Manager at 561-494-3673.

    Distribution

    USA Distribution to the states of : AR, AZ, CA, CO, FL, IL, IN, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OK, OR, PA, SC, TN, TX, VA, WA, WI and Hawaii

    Quantity

    1,992