BEUDAMED
    FDA Enforcement Class II Terminated

    InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, a Mixing System, Targeting K-Wires and a Delivery Needle (Cannula). Model number 10801210. InjectionPlasty 1.0 is indicated to fill bony voids or gaps of the skeletal system

    Recall: Z-2209-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2209-2015
    Event ID
    71459
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skeletal Kinetics, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 5, 2015
    Initiation Date
    May 29, 2015
    Classification Date
    July 24, 2015
    Termination Date
    July 24, 2015
    Address
    10201 Bubb Rd, N/A, Cupertino, CA, 95014-4167, United States

    Description

    InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty 1.0 sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, a Mixing System, Targeting K-Wires and a Delivery Needle (Cannula). Model number 10801210. InjectionPlasty 1.0 is indicated to fill bony voids or gaps of the skeletal system

    Reason

    Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.

    Code Info

    Model number: 10801210: Lot Numbers Expiration Dates 13022501 8/31/2015 13052305 11/30/2015 13120901 5/31/2016 14051901 11/30/2016 14100101 3/31/2017 15042701 10/13/2017

    Distribution

    US Distribution including Puerto Rico.

    Quantity

    67 kits