Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), 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 CTIMR 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 |
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| Recall Number | Z-2428-2012 |
| Classification | Class II |
| Code Info | All lot numbers from 2002 to current |
| Product Distributed Qty | 175 units |
| 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 |
Event Detail
| Event Id | 62978 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Integra LifeSciences Corporation |
| City | Plainsboro |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
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