InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized usi
FDA device recall Z-2209-2015 · posted 2015-07-24 · Terminated
Recall details
- Recalling firm
- Skeletal Kinetics, Llc
- Reason for recall
- Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
- Action taken
- 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 duran@skeletalkinetics.com.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 67 kits
- Distribution
- US Distribution including Puerto Rico.
- Date initiated
- 2015-05-29
- Date posted
- 2015-07-24
- Date terminated
- 2015-07-24
- Location
- Cupertino, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CALLOS IMPACT AND INJECT BONE VOID FILLER (K051123) | Skeletal Kinetics, LLC | 2005-06-03 |