BEUDAMED
    FDA Enforcement Class II Ongoing

    Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

    Recall: Z-1159-2021 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1159-2021
    Event ID
    87258
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ReNovo, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 10, 2021
    Initiation Date
    January 19, 2021
    Classification Date
    March 2, 2021
    Address
    340 Sw Columbia St, Bend, OR, 97702-1035, United States

    Description

    Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

    Reason

    Non-sterile product was shipped to customers labelled as sterile.

    Code Info

    Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045 Lot numbers L-008936-16275, and L-008933-16078

    Distribution

    US Nationwide distribution in the states of CA, NJ and OR.

    Quantity

    81 units