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.
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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Integra LifeSciences Corporation is recalling the CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), and HRAIM Head Ring Assembly with Intubation Mounts. The recall involves 175 units distributed worldwide, including the United States and various international markets. The affected products include all lot numbers from 2002 to the current date.
The recall is due to a defect in the T-handle screw used on the HRAIM intubation hoop. When tightened, the T-handle may stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring, even though the system appears to be fully seated. This issue could compromise the precision of the stereotactic system used for localizing intracranial targets.
Healthcare facilities and users of these devices should stop using the affected units and contact Integra LifeSciences Corporation for further instructions on repair or replacement. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.…
- Manufacturer
- Integra LifeSciences Corporation
- Affected units
- 175
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.
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