DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 6,979 Confidence Spinal Cement System Side Fire Needles due to reports of breakage. The needles are used to place bone cement in the spine.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 for spinal surgery, which poses a risk of significant injury.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling 6,979 units of the Confidence Spinal Cement System Side Fire Needles (13G x 4IN, Product Code 283904413). The recall was initiated due to reports of breakage with the side fire needles. These needles are used to place bone cement in an intra-vertebral fashion at a desired location, with the cement extruding through a port on the side of the needle.
The affected products were distributed worldwide, including the United States (nationwide), Canada, and various countries in Europe, Asia, Africa, and the Middle East. All lots of the product are included in this recall.
The FDA has classified this as a Class II recall. Healthcare providers and facilities should stop using the affected needles and contact DePuy Mitek for instructions on returning the product.
The recalled product
- Product
- 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…
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 6,979
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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