Z-1940-2012 Class II Terminated
FDA device recall Z-1940-2012 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on May 4, 2012 and is designated Class II. Reason for recall: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles The recall status is terminated (terminated Aug 4, 2016). Affected quantity: 6979 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 11, 2012
- Initiation Date
- May 4, 2012
- Termination Date
- Aug 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6979 units
Product description
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 intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Reason for recall
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
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.
Code information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1940-2012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026