BEUDAMED
    FDA Recall Open, Classified

    Synthes Small Electric Drive (SED)

    Recall: Z-1017-2016 · Initiated November 14, 2014

    Recall

    Recall Number
    Z-1017-2016
    Event Number
    69974
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HTC
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    November 14, 2014
    Posted
    February 25, 2016
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    Synthes Small Electric Drive (SED)

    Reason

    May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

    Action

    On November 13, 2014 DePuySynthes sent a letter to all their consignees informing them of the recall and asked them to return the product. A letter and a response letter were sent to all customers that received the device. For contact - The Complaint Handling Unit Manager at 561-494-3673 or the customer DePuy Synthes Sales Consultant.

    Distribution

    CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.

    Quantity

    302 (23 in the USA and 279 OUS)