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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Skeletal Kinetics, Llc
- Reason for Recall:
- Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2209-2015
Related Recalls
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.