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.
This recall has been terminated (originally issued February 23, 2011).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- January 12, 2011
- Posted
- February 23, 2011
- Terminated
- April 4, 2011
- Recall Number
- Z-1400-2011
- Quantity
- 8 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution - USA, Canada, and Australia
Lot / Code Info
Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
Root Cause
Manufacturing material removal
Action Taken
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.