BEUDAMED
    FDA Recall Terminated

    Synthes Small Electric Drive (SED). For use in general traumatology.

    Recall: Z-0747-2016 · Initiated August 14, 2014

    Recall

    Recall Number
    Z-0747-2016
    Event Number
    73000
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HTC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 14, 2014
    Posted
    February 3, 2016
    Terminated
    February 5, 2016
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    Synthes Small Electric Drive (SED). For use in general traumatology.

    Reason

    The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

    Action

    On 11/13/2014 DePuy Synthes send a letter to all their customers informing them of the recall of all the lots of the Small Electric Drive (SED) with instructions to returned and possible exchange. Contact is Complaint Handling Unit Manager at 561-494-3673

    Distribution

    Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.

    Quantity

    599 each