Recall Z-2429-2012— Integra LifeSciences Corporation

Name: FDA recall Z-2429-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-09

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2012-08-09, terminated 2014-03-26. It names one FDA 510(k) clearance: K944463. Product: Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes. Reason: 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.

Recalling firm: Integra LifeSciences Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Terminated: 2014-03-26
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K944463 — CRW-1 SYSTEMRadionics Software Applications, Inc.·cleared 1995-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.