Crw-1 System

• • Terminated Z-0025-2016 FDA Class II ·initiated 21 Aug 2015

  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.

• 2 recalls, same reason

  • Terminated Z-2428-2012 FDA Class II ·initiated 9 Aug 2012
  • Terminated Z-2429-2012 FDA Class II ·initiated 9 Aug 2012

  T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated

• • Terminated Z-1400-2011 FDA Unclassified (pre-2012) ·initiated 12 Jan 2011

  Overall length of the intubation hoop in the HRAIM Intubation Head Ring Assembly is too long and will not allow a device to to attach

510(k) Number

K944463 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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