BEUDAMED
    FDA Recall Terminated

    OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.

    Recall: Z-0398-2018 · Initiated September 29, 2017

    Recall

    Recall Number
    Z-0398-2018
    Event Number
    78901
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 29, 2017
    Posted
    January 11, 2018
    Terminated
    July 30, 2019
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.

    Reason

    This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.

    Action

    On November 15, 2017 the firm sent letter to their only consignee. Our records show that your facility has received the product subject to this removal. 1. Immediately review your inventory to identify and quarantine the affected product listed above in a manner that ensures the affected product will not be used. 2. Review, complete, sign and return the attached reply form on page 3 of this letter to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return the affected product as soon as possible, but within 30 business days. 4. Forward this notice to anyone in your facility who needs to be informed. 5. If the affected product has been forwarded to another facility, contact that facility to arrange its return. 6. Maintain awareness of this notice until the product has been returned. 7. Keep a copy of this notice. We apologize for any inconvenience that this product recall (removal) may create and appreciate your cooperation with our request. Should you have any inquiries please do not hesitate to contact your DePuy Synthes sales consultant. Thank you for your attention and cooperation. For further questions, please call (610) 314-2106.

    Distribution

    Internationally to Canada

    Quantity

    1