CLASS II Device recall · Reported 11 Jul 2012 · FDA Enforcement Report
Depuy Spine Side Fire Needles Side-Fire Needle recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling Depuy Spine Side Fire Needles Side-Fire Needle, part of the Confidence Spinal Cement, distributed nationwide in the US. The recall was initiated on 4 May 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1939-2012
- FDA event ID
- 61874
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2012
- FDA classified
- 3 Jul 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 4 May 2012 | Recall initiated by company | |
| 3 Jul 2012 | Classified by FDA | +60 days |
| 11 Jul 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 the side of the needle.
Where it was distributed
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.
Questions about this recall
Is Depuy Spine Side Fire Needles Side-Fire Needle, part of the Confidence Spinal Cement recalled?
Yes. DePuy Mitek, Inc., a Johnson & Johnson recalled Depuy Spine Side Fire Needles Side-Fire Needle, part of the Confidence Spinal Cement on 4 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1939-2012.
Why was it recalled?
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Which lots are affected?
All lots
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DePuy Mitek, Inc., a Johnson & Johnson
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | COR Disposable Kit w/ Perpendicularity recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | COR Disposable Kit Cartilage Transplant System recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |