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.
What this means for you
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 used
- Manufacturer
- Integra LifeSciences Corporation
- 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 →- ModerateIntegra Meshed Dermal Regeneration Template Recalled for Calculation Error
FDA (Devices) · 2016-09-21
- HighIntegra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure
FDA (Devices) · 2015-02-18
- ModerateIntegra Newdeal SURFIX Screws Recalled for Packaging Labeling Error
FDA (Devices) · 2014-06-11
- HighIntegra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
FDA (Devices) · 2013-07-24
- HighIntegra Recalls BioMend Extend Membranes Due to Pyrogen Levels
FDA (Devices) · 2013-05-22
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12