BEUDAMED
    FDA Recall Terminated

    Segmental fluted stem, 18x250mm bwd, Sterile,

    Recall: Z-2574-2017 · Initiated February 28, 2017

    Recall

    Recall Number
    Z-2574-2017
    Event Number
    76629
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 28, 2017
    Posted
    March 20, 2017
    Terminated
    February 27, 2018
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Segmental fluted stem, 18x250mm bwd, Sterile,

    Reason

    Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

    Action

    Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to [email protected] within three (3) days. 3. Assist the Zimmer Biomet sales representative quarantine all affected product. 4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by email to [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing [email protected]. For questions regarding this recall call 574-371-3071.

    Distribution

    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand

    Quantity

    9867