BEUDAMED
    FDA Recall Completed

    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

    Recall: Z-2213-2023 · Initiated April 26, 2023

    Recall

    Recall Number
    Z-2213-2023
    Event Number
    92621
    Firm
    Materialise N.V. Technologielaan 15 Heverlee Belgium
    FEI Number
    3003998208
    Product Code
    JWH
    Status
    Completed
    Root Cause
    Process control
    Initiated
    April 26, 2023
    Posted
    July 20, 2023

    Description

    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

    Reason

    The wrong tibia guide was included intended for a different patient case.

    Action

    Materialise notified Zimmer Biomet international logistics on April 26, 2023 via email and telephone requested return of cases. Zimmer BIomet confirmed that they would directly contact the customer to return the original cases ZB23-MAN-OLA and ZB22-UHI-NEF. Materialise shipped replacement cases on May 2, 2023 and May 3, 2023. For questions call +1-734-259-7010 or email: [email protected].

    Distribution

    International Distribution to countries of: Germany, Netherlands

    Quantity

    2 Guides