Class II — Integra LifeSciences Corporation
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 188 units |
| Distribution | 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. |
| Initiated | 2012-08-09 |
| Classified | 2012-09-20 |
| Terminated | 2014-03-26 |
| Recall number | Z-2429-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corporation (Z-2429-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62978/
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