Drug recall
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411…
FDA recall event 61874 · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.
Key facts
| Event ID | 61874 |
|---|---|
| Recall numbers | Z-1937-2012, Z-1938-2012, Z-1939-2012, Z-1940-2012 |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Product type | Devices |
| Products | 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…, 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…, Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an…, Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles |
| Initiation date | May 4, 2012 |
| Report date | Jul 11, 2012 |
| Termination date | Aug 4, 2016 |
| City | Raynham |
| State | MA |
| Country | United States |
| FEI number | 1221934 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: