Skeletal Kinetics, Llc: Medical Device Recall in 2015 - (Recall #: Z-2209-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: May 29, 2015

Date Posted: August 5, 2015

Recall Number: Z-2209-2015

Event ID: 71459

Reason for Recall:

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

Status: Terminated

Product Quantity: 67 kits

Code Information:

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 Pattern:

US Distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated