[Recalled] Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a de
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. 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 th |
|---|---|
| Brand / manufacturer | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1939-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 May 2012 |
| EAN / barcode | 283904611 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from DePuy Mitek, Inc., a Johnson & Johnson Co.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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