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

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

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 [email protected].