BEUDAMED
    FDA Enforcement Class II Terminated

    OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.

    Recall: Z-1526-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1526-2020
    Event ID
    85036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    XTANT MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    May 3, 2019
    Classification Date
    March 19, 2020
    Termination Date
    December 17, 2020
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719, United States

    Description

    OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.

    Reason

    The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.

    Code Info

    Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.

    Distribution

    US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees.

    Quantity

    26