BEUDAMED
    FDA Enforcement Class II Terminated

    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10

    Recall: Z-1945-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1945-2018
    Event ID
    80080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olsen Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    May 11, 2018
    Classification Date
    May 25, 2018
    Termination Date
    April 15, 2019
    Address
    3230 Commerce Center Pl, N/A, Louisville, KY, 40211-1900, United States

    Description

    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10

    Reason

    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

    Code Info

    all codes

    Distribution

    Worldwide Distribution

    Quantity

    4,110 devices