DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 530 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) in a medical device used during spinal surgery, which poses a significant risk of injury.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 530 units of the Confidence Spinal Cement System Side Fire Needles (Product Code 283904611). The recall is being conducted due to reports of breakage with the side fire needles.
The affected product is an 11G x 6IN Side-Fire Needle used to place bone cement in an intra-vertebral fashion. The cement extrudes from the needle through a port on the side. The recall covers all lots of this specific product code.
The product was distributed worldwide, including the United States (nationwide), 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 the UK. Healthcare providers and facilities should stop using the affected needles and contact DePuy Mitek for further instructions.
The recalled product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 530
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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