Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. |
|---|---|
| Recall Number | Z-0412-2013 |
| Classification | Class II |
| Code Info | Lot Numbers: SFP02323, SFP02323R, and SFP02323RR |
| Product Distributed Qty | 17 units |
| Reason For Recall | Inspan Compressors may break at weld causing a loss of compression |
Event Detail
| Event Id | 63144 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | SpineFrontier, Inc. |
| City | Beverly |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-28 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico. |
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