The Recall Desk

FDA (Devices) recall action 62978

Integra LifeSciences Corporation recalled 2 products on 2012-09-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-09-26
Critical
0
Units
363

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2012-09-26

    Integra HRAIM Head Ring Assembly Recalled for T-Handle Seating Issue

    Integra LifeSciences is recalling HRAIM Head Ring Assemblies because a T-handle screw may prevent the CRW stereotactic system from seating properly.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-26

    Integra CRW Precision Arc and HRAIM Head Ring Assembly Recalled

    Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.

    Product
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), 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 CTIMR compatible. T
    Category
    Distribution
    0 states