FDAAugust 20, 2015device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

orthovita inc dba stryker orthobiologicsorthovitaorthovita inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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