BEUDAMED
    FDA Recall Terminated

    Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663

    Recall: Z-0124-2007 · Initiated September 7, 2006

    Recall

    Recall Number
    Z-0124-2007
    Event Number
    36240
    Firm
    Hydrocision, Inc.
    FEI Number
    3003018854
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 7, 2006
    Posted
    November 2, 2006
    Terminated
    December 6, 2006
    Address
    22 Linnell Cir, Ste 102, Billerica, MA, 01821-3901

    Description

    Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663

    Reason

    Distal tip may become detached from the device

    Action

    Hydrocision contacted customers and sales reps by email on 9/6/06 advising to users to discontinue use and return recalled units.

    Distribution

    Nationwide.

    Quantity

    40 total