Device Recall InjectionPlasty 1.0

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

Orthopedic Devices

2

Yes

US Distribution including Puerto Rico.

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