BEUDAMED
    FDA Enforcement Class II Terminated

    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

    Recall: Z-1137-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1137-2022
    Event ID
    90022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ProgenaCare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2022
    Initiation Date
    April 18, 2022
    Classification Date
    May 26, 2022
    Termination Date
    April 14, 2023
    Address
    2275 Northwest Pkwy Se Ste 175, Marietta, GA, 30067-9321, United States

    Description

    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

    Reason

    Inner pouch seal may be inadequate resulting in lack of sterility.

    Code Info

    (1) Model PM2012, lot #02SEP21-001, exp. 4/9/2024; lot #29SEP21-001, exp. 4/9/2024. (2) Model PM3002, lot #28OCT21-001, exp. 3/7/2024. (3) Model PM3004, lot #02DEC21-001, exp. 10/1/2023; lot #02SEP21-002, exp. 10/1/2023; lot #14OCT21-001, exp. 10/1/2023; and 23NOV21-001, exp. 10/1/2023. (4) Model PM3006, lot #02SEP21-003, exp. 10/1/2023; lot #03DEC21-001, exp. 10/1/2023; lot #14OCT21-002, exp. 10/1/2023; and lot #23NOV21-002, exp. 10/1/2023. (5) Model PM3010, lot #13JUL21-001, exp. 10/1/2023; and lot #15JUL21-002, exp. 3/6/2024.

    Distribution

    US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.

    Quantity

    547 packages