FDA-Device2015-10-14Class II
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.
Integra LifeSciences Corp.
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.
Sold states
Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.
Affected count
6 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0025-2016Don't want to check this manually?
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