FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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.
- Recall number
- Z-1400-2011
- Recalling firm
- Integra LifeSciences Corp.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-01-12
- Posted
- 2011-02-23
- Terminated
- 2011-04-04
- Reason
- 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
- Root cause
- Manufacturing material removal
- Action
- 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 james.tillman@integraJife.com.
- Quantity
- 8 units
- Distribution
- Worldwide Distribution - USA, Canada, and Australia
- Lot, serial or model codes
- Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
- 510(k) numbers
- ["K944463"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28