Device recall
Z-2209-2015: InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium…
FDA device recall · Class II · Skeletal Kinetics, Llc
Key facts
| Recall number (Z-number) | Z-2209-2015 |
|---|---|
| Recall event | 71459 |
| 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… |
| Product code | MQV |
| Recalling firm | Skeletal Kinetics, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2015 |
| 510(k) numbers | K051123 |
| FEI number | 3003890476 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database