The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2429-2012·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that could lead to improper seating of a surgical system, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Integra LifeSciences Corporation is recalling 188 units of the HRAIM Head Ring Assembly with Intubation Mounts. The recall covers all lot numbers from 2002 to the current date. The product was distributed worldwide, including the United States and various international markets such as Canada, the UK, and Australia.

The recall is due to a mechanical issue with the T-handle screw used on the HRAIM intubation hoop. When the T-handle is tightened, it may stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL stereotactic systems from seating properly on the head ring. This can occur even if the system appears to be fully seated.

The HRAIM head ring is used in conjunction with the CRW stereotactic system, which is a multi-purpose system used for localizing intracranial targets for procedures such as biopsies and electrode placement. Users should contact Integra LifeSciences Corporation for further instructions regarding the recall.

The recalled product

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…
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
188

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lot numbers from 2002 to current

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Integra LifeSciences Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Integra LifeSciences Corporation

See all →

Same hazard · mechanical defect

See all →

Similar recalls