Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW… — Class II medical device recall Z-2429-2012
Terminated recall by Integra LifeSciences Corporation, reported 2012-09-26, distributed nationwide. T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible in
| Recall number | Z-2429-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corporation, Plainsboro, NJ, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2014-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, CA, CN, DK, ES, FR, GB, HK, HU, IT, JP, MY, PH, SG, ZA |
| Quantity | 188 units |
Product
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2429-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.