Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the general stereotactic treatment
FDA device recall Z-1400-2011 · posted 2011-02-23 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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
- 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.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 8 units
- Distribution
- Worldwide Distribution - USA, Canada, and Australia
- Date initiated
- 2011-01-12
- Date posted
- 2011-02-23
- Date terminated
- 2011-04-04
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRW-1 SYSTEM (K944463) | Radionics Software Applications, Inc. | 1995-10-26 |