FDAAugust 21, 2015device
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
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