Events

Recall of Device Recall InjectionPlasty 1.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Skeletal Kinetics, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71459
  • Event Risk Class
    Class 2
  • Event Number
    Z-2209-2015
  • Event Initiated Date
    2015-05-29
  • Event Date Posted
    2015-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137879
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filler, bone void, calcium compound - Product Code MQV
  • Reason
    Reports of venous uptake, dvt, pulmonary embolism in patients who were implanted with injection plasty bone void filler.
  • Action
    Skeletal Kinetics sent letters to distributors by overnight mail with instructions to forward a Dear Doctor notification letter on May 14, 2015. Second letters dated May 29, 2015, advised that the firm is removing the product from the marker. Distributor letters asked that the Dear Doctor letter be forward within 24 hours of receipt of the letter. All Injection Plasty kits in their possession and those with customers should be retrieved and returned by Fed Ex. Dear Doctor letters advised that their distribution agent has been requested to return all unused kits. Questions may be directed to 408-366-5002 of duran@skeletalkinetics.com.

Device

Device Recall InjectionPlasty 1.0
  • Model / Serial
    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
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including Puerto Rico.
  • Product 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
  • Manufacturer
    Skeletal Kinetics, Llc

Manufacturer

Skeletal Kinetics, Llc
  • Manufacturer Address
    Skeletal Kinetics, Llc, 10201 Bubb Rd, Cupertino CA 95014-4167
  • Manufacturer Parent Company (2017)
    Skeletal Kinetics Llc
  • Source
    USFDA