Recall Z-1400-2011 ยท HAW Neurological Stereotaxic Instrument
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
| Date | Feb 23, 2011 (initiated Jan 12, 2011) |
| Status | Terminated |
| 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@i |
| Quantity | 8 units |
| Distribution | Worldwide Distribution - USA, Canada, and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944463 | CRW-1 SYSTEM Radionics Software Applications, Inc., Oct 26, 1995 |