FDA Device recall Z-2209-2015
InjectionPlasty 1.0 Bone Void Filler
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of InjectionPlasty 1.0 Bone Void Filler by Skeletal Kinetics, citing reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2209-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Skeletal Kinetics |
| Distribution | PR |
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.
Identifiers
| code_info | Model number: 10801210: Lot Numbers Expiration Dates 13022501 8/31/2015 13052305 11/30/2015 13120901 5/31/2016 14…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2015%22
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