Recall Z-2209-2015 ยท MQV Filler, Bone Void, Calcium Compound
Skeletal Kinetics, Llc
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 an
| Date | Jul 24, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler. |
| Root cause | No Marketing Application |
| Action | 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 |
| Quantity | 67 kits |
| Distribution | US Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051123 | CALLOS IMPACT AND INJECT BONE VOID FILLER Skeletal Kinetics, LLC, Jun 3, 2005 |