Recalls / —
—#97501
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.
- FDA product code
- HAW — Neurological Stereotaxic Instrument
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K944463
- Affected lot / code info
- Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
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
Root cause (FDA determination)
Manufacturing material removal
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Worldwide Distribution - USA, Canada, and Australia
Timeline
- Recall initiated
- 2011-01-12
- Posted by FDA
- 2011-02-23
- Terminated
- 2011-04-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #97501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.