BEUDAMED
    FDA Recall Terminated

    Light Adaptor for Small Battery Drive and Small Battery Drive II.

    Recall: Z-2783-2016 · Initiated June 24, 2016

    Recall

    Recall Number
    Z-2783-2016
    Event Number
    74835
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 24, 2016
    Posted
    September 27, 2016
    Terminated
    June 9, 2018
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    Light Adaptor for Small Battery Drive and Small Battery Drive II.

    Reason

    There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

    Action

    An Urgent Notice for this Recall was provided to the consignees on 6/24/2016. They were to review their inventory and return the products with instructions. IF YOU HAVE ANY PRODUCT: To immediately quarantine product so it's not used; ensure all in their facility read the Urgent Notice for the Recall; Call the DePuy Synthes Customer Support to obtain a Return Materials Authorization (RMA) Number; to complete the Verification Section indicating the product subject to recall was located; to return the Verification Section with the product to Product Returns, The Anspach Effort Inc., 4500 Riverside Drive, Palm Beach Gardens, FL 33410; Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Dept by: FAX (561) 627-2682 or Scan/email: [email protected]; Keep the notice visibly posted for awareness until all products have been returned; maintain a copy of the notice subject to this action and keep a copy for your records. The return documentation acknowledges your receipt of the medical device removal information. IF YOU DO NOT HAVE the identified product: complete the Verification Section of the recall, by checking the box indicating no affected product located; Include your name title, address, telephone #, signature and date; Send a copy of the completed Verification Section to DePuy Synthes Customer Quality Dept by: Fax: (561) 627-2682, or Scan/e-mail: [email protected]; This return document acknowledges your receipt of medical device removal information; ADVISORY: For Alternative products: This product does not have any inventory for replacement. Since the recall of this device may have an impact on your surgical schedule, DePuy Synthes Power Tools would like to propose alternative products to assist you with a replacement for the Recalled Adaptor (05.100.024) or Light Adaptor (05.001.108) . The products are the Small Battery Drive II Hand-piece (532.110) can also be operated

    Distribution

    Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.

    Quantity

    1,833 devices (05.001.024 and 05.001.108)