Integra Radionics HRAIM Intubation Head Ring Assembly recallZ-1400-2011 · Integra LifeSciences Corp. · initiated Jan 12, 2011
Terminated All recalls posted in February 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Overall length of the intubation hoop in the HRAIM Intubation Head Ring Assembly is too long and will not allow a device to to attach
FDA root cause category: Manufacturing material removal
What the company is doing
Integra sent a Medical Device Field Corrective Action letter dated January 12, 2011, to all affected customers via Federal Express. Integra Sales Specialists were provided with the replacement part and written instructions on how to replace the affected intubation hoops from customer inventory identified in the traceability report. Upon completion of the field correction each sales specialist was instructed to return the affected hoop along with a completed copy the Recall Acknowledgement and Return Form. If additional information is required contact me at (609) 936-2485 or [email protected].
Recall details
- Recall number
- Z-1400-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 12, 2011
- Posted by the FDA
- Feb 23, 2011
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 8 units
- Product code
- HAW
- FDA submissions
- K944463
- Distribution
- Worldwide Distribution - USA, Canada, and Australia
Product description
Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation used for precise spatial localization and treatment of physiologic targets for stereotactic neurosurgical procedures such as craniotomies, biopsies, functional neurosurgery, and radiation therapy. Head Rings are delivered to the user non-sterile, and are reusable.
Code information (models, lots, serial numbers)
Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
Other devices under the same FDA submission
2 devices cleared under K944463 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CRW® HRAIMIntegra Lifesciences Corporation · Neurological stereotaxic Instrument1 report
- Integra® UCHRAIntegra Lifesciences Corporation · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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