BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 30, 2020

    Recall

    Recall Number
    Z-0401-2021
    Event Number
    86572
    Firm
    Merz North America, Inc.
    FEI Number
    3003407669
    Product Code
    LNM
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    September 30, 2020
    Address
    4133 Courtney Rd, Ste 10, Franksville, WI, 53126-9127

    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.

    Action

    Merz NA, in cooperation with Boston Scientific Corporation (BSC) have prepared field action communications including a Medical Device Field Notification Letter and Urgent Medical Device Field Notification Response Form. These letters will be sent via FedEx with delivery confirmation. The units at consignees will not be returned but will be furnished with an updated, revision-controlled IFU.

    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