BEUDAMED
    FDA Recall Terminated

    ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955

    Recall: Z-0391-2020 · Initiated September 27, 2018

    Recall

    Recall Number
    Z-0391-2020
    Event Number
    84004
    Firm
    Orthofix Srl Via Delle Nazioni
    FEI Number
    3002807827
    Product Code
    JDW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 27, 2018
    Terminated
    February 1, 2022
    Address
    9 O 73 Veronaverona Italy

    Description

    ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955

    Reason

    As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

    Action

    On 10/01/2018, Orthofix provided distributor, doctors, and hospitals a urgent medical device recall notification via FedEx overnight carrier . The letter asked consignees to take the following actions: 1. Immediately cease any further distribution of the affected devices; 2. Notify hospitals, surgeons and others to whom you may have distributed affected devices that such devices cannot be used and must be returned to Orthofix according to the instructions below; 3. Complete the Acknowledgement Form indicating that you have received this notification. It should be returned by email or fax to the contact details on the attached form. 4. Subsequent Distribution: If your firm has provided or sold the affected products to other users, please provide a list of those users to the undersigned and forward this notification to them to assure prompt action. 5. Product Return Instructions: To return the devices affected by this action, please follow these instructions: A - Check your inventory for the devices affected by this action; B - Complete the attached Acknowledgement Form with the quantity you are returning; C - Contact Orthofix Customer Service at (800) 266-3349 for return instructions and replacement information

    Distribution

    US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel