Orthovita, Inc., dBA Stryker Orthobiologics. recalls Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone…

Recall date

August 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2772-2015

FDA classification

Class II

Brand / firm

Orthovita, Inc., dBA Stryker Orthobiologics.

Sold / distributed

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.

Why it was recalled

Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone