Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. |
|---|---|
| Recall Number | Z-1938-2012 |
| Classification | Class II |
| Code Info | All lots |
| Product Distributed Qty | 704 units |
| Reason For Recall | Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles |
Event Detail
| Event Id | 61874 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| City | Raynham |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK. |
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