BEUDAMED
    FDA Recall Terminated

    Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.

    Recall: Z-1553-2015 · Initiated March 24, 2015

    Recall

    Recall Number
    Z-1553-2015
    Event Number
    70919
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 24, 2015
    Posted
    April 30, 2015
    Terminated
    December 14, 2016
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235

    Description

    Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.

    Reason

    The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.

    Action

    DePuySynthes sent a "URGENT NOTICE: MEDICAL DEVICE RECALL- CORRECTION" letter dated March 24, 2015 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers review the inventory and perform the in-process inspection outlined in the letter attachment, a review and repair will be implemented if necessary during the next visit schedule maintenance interval at the customer site. Customers having questions regarding this notice should contact the firm Complaint Handling Unit Manager at 561-494-3673 or to contact their Depuy Synthes Sales Consultant. For questions regarding this recall call 561-627-1080.

    Distribution

    Worldwide Distribution - US (nationwide including DC, Hawaii, and Puerto Rico) and Internationally to Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Brazil, Canada, China, Chile, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Lebanon, Sri Lanka, Libyan Arab Jamahiriya, Morocco, Macedonia, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Ontario, Peru, Philippines, Palestine, Portugal, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, South Africa, El Salvador, Thailand, Turkey, Taiwan, Ukraine, Uruguay, Venezuela, Vietnam and United Arab Emirates.

    Quantity

    12,085 pieces