BEUDAMED
    FDA Enforcement Class II Ongoing

    COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.

    Recall: Z-0401-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0401-2021
    Event ID
    86572
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merz North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2020
    Initiation Date
    September 30, 2020
    Classification Date
    November 16, 2020
    Address
    4133 Courtney Rd Ste 10, N/A, Franksville, WI, 53126-9127, United States

    Description

    COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.

    Reason

    The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

    Code Info

    Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

    Distribution

    US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV

    Quantity

    2051 units