Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI |
|---|---|
| Recall Number | Z-0351-2013 |
| Classification | Class II |
| Code Info | Batch: JK2042, JK2080, JK2151 |
| Product Distributed Qty | 240 units total |
| Reason For Recall | The tulip portion of the screw assembly can disengage from the shank after implantation. |
Event Detail
| Event Id | 52634 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | NuVasive Inc |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2009-01-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. |
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