BEUDAMED
    FDA Recall Terminated

    V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    Recall: Z-2324-2016 · Initiated June 27, 2016

    Recall

    Recall Number
    Z-2324-2016
    Event Number
    74548
    FEI Number
    3005233524
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2016
    Posted
    August 2, 2016
    Terminated
    May 30, 2017
    Address
    Zimmer Gmbh Sulzer Allee 8 Winterthur Switzerland

    Description

    V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    Reason

    Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.

    Action

    Zimmer GmbH initiated a voluntary recall of the Normed - TWIST DRILL Cannulated & Normed- V-TEK TWIST DRILL Cannulated, with written notices on June 27, 2016 via certified mail due to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. Customers are asked to do the following: Review the notification and ensure affected personnel are aware of the contents. 2. Locate all affected product identified above and quarantine them immediately. 3. Return any affected product within your possession. Clearly mark the outside of all return packages, Recall, and include a copy of the Inventory Return Certification form (Attachment 1) with your return shipment(s). 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Online:www.fda.gov/medwatch/report.htm " Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. " Fax: 1-800-FDA-0178 Affected units returned as part of this recall activity will be scrapped

    Distribution

    Domestic: CO, IL Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay

    Quantity

    169