FDA Device recall Z-1938-2012
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411
- FDA Device
- Class II
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class II recall of Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411 by Depuy Mitek A Johnson And Johnson, citing additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1938-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-04 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | US |
Product
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.
Reason
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1938-2012%22
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