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Recall Observatory FDA recall evidence

Device product

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.

Z-0025-2016

August 21, 2015

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 72068
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0025-2016

Official wording

Reason: 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.

Code information: Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906

Distribution pattern: Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    error in the manufacturing