CLASS II Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
Integra Hraim Head Ring Assembly recalled by Integra LifeSciences
Integra LifeSciences is recalling Integra Hraim Head Ring Assembly with Intubation Mounts The CRW stereotactic system is, distributed nationwide in the US. The recall was initiated on 9 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2429-2012
- FDA event ID
- 62978
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Aug 2012
- FDA classified
- 20 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 9 Aug 2012 | Recall initiated by company | |
| 20 Sep 2012 | Classified by FDA | +42 days |
| 26 Sep 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Product as listed by the FDA
Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Where it was distributed
Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
Stores named: Target
Questions about this recall
Is Integra Hraim Head Ring Assembly with Intubation Mounts The CRW stereotactic system is recalled?
Yes. Integra LifeSciences recalled Integra Hraim Head Ring Assembly with Intubation Mounts The CRW stereotactic system is on 9 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-2429-2012.
Why was it recalled?
T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Which lots are affected?
All lot numbers from 2002 to current
Where was it sold?
Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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