InjectionPlasty 1 — Class II medical device recall Z-2209-2015
Terminated recall by Skeletal Kinetics, Llc, reported 2015-08-05, distributed in PR. Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Vo
| Recall number | Z-2209-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skeletal Kinetics, Llc, Cupertino, CA, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-07-24 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2015-07-24 |
| Distributed | PR |
| Quantity | 67 kits |
| Lot numbers | 13022501, 13052305, 13120901, 14051901, 14100101, 15042701 |
| Model numbers | 10801210 |
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 for recall
Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2209-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.