FDA-Device2015-09-23Class II
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Orthovita, Inc., dBA Stryker Orthobiologics.
Hazard
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
Sold states
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Affected count
9805
Manufactured in
45 Great Valley Pkwy, Malvern, PA, United States
Products
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2772-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief