Recall Z-2209-2015— Skeletal Kinetics, Llc

Name: FDA recall Z-2209-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-29

Class II · Terminated

Class II FDA medical device recall by Skeletal Kinetics, Llc, initiated 2015-05-29, terminated 2015-07-24. It names one FDA 510(k) clearance: K051123. Product: 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..

Recalling firm: Skeletal Kinetics, Llc
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Terminated: 2015-07-24
Firm location: Cupertino, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051123 — CALLOS IMPACT AND INJECT BONE VOID FILLERSkeletal Kinetics, LLC·cleared 2005-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.