BEUDAMED
    FDA Enforcement Class II Terminated

    - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument

    Recall: Z-1635-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1635-2013
    Event ID
    65205
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Surgical Instrument Service And Savings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    May 3, 2013
    Classification Date
    July 1, 2013
    Termination Date
    July 11, 2013
    Address
    2747 Sw 6th St, N/A, Redmond, OR, 97756-7109, United States

    Description

    - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument

    Reason

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

    Code Info

    122347, 122289, 122322, 122511.

    Distribution

    Nationwide Distribution.

    Quantity

    10