International Medical Devices Database

Manufacturer Address
Skeletal Kinetics, Llc, 10201 Bubb Rd, Cupertino CA 95014-4167
Manufacturer Parent Company (2017)
Skeletal Kinetics Llc
Source
USFDA
1 Event
- Recall of Device Recall InjectionPlasty 1.0

One device in the database

Device Recall InjectionPlasty 1.0

Model / Serial
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
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution including Puerto Rico.
Product 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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Skeletal Kinetics, Llc

One device in the database

Device Recall InjectionPlasty 1.0