BEUDAMED
    FDA Enforcement Class II Terminated

    Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.

    Recall: Z-0104-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0104-2019
    Event ID
    80734
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Valeris Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    July 16, 2018
    Classification Date
    October 12, 2018
    Termination Date
    August 4, 2020
    Address
    200 Cobb Pkwy N Bldg 200 Ste 210, N/A, Marietta, GA, 30062-3500, United States

    Description

    Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.

    Reason

    The product was mislabeled as containing the incorrect type of suture.

    Code Info

    Lot #1982, Exp. 3/22/2019

    Distribution

    Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand.

    Quantity

    75 units