DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 704 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 risk of significant injury.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 704 units of Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System (Product Code: 283904411). The recall is issued due to reports of breakage with the side fire needles.
The Confidence Side Fire Needle is a medical device used to place bone cement in an intra-vertebral fashion at a desired location, with the cement extruding from the needle through a port on the side. The affected units were distributed worldwide, including the United States (nationwide), Canada, and various countries in Europe, Asia, Africa, and the Middle East.
This recall applies to all lots of the product. Healthcare providers and facilities should stop using the affected needles and contact DePuy Mitek for further instructions regarding the return or replacement of the devices.
The recalled product
- 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
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Affected units
- 704
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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