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Orthovita, Inc., dBA Stryker Orthobiologics. recalls Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone
Recalled September 23, 2015 · FDA recall Z-2772-2015 · Orthovita, Inc.,
Hazard
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration · FDA Class II
Units
9805
Sold at
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.
Description
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
Product
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Manufacturer(s)
Orthovita, Inc., dBA Stryker Orthobiologics.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →