BEUDAMED
    FDA Recall Terminated

    ROSA Surgical Device 2.5.8

    Recall: Z-0178-2018 · Initiated February 10, 2013

    Recall

    Recall Number
    Z-0178-2018
    Event Number
    77672
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 10, 2013
    Terminated
    June 9, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    ROSA Surgical Device 2.5.8

    Reason

    Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.

    Action

    Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.

    Distribution

    AR, OH, MI, and TX

    Quantity

    22 units (4 US and 18 OUS)