Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. Due to Additional Instructions for Use and Surgical Technique for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Mitek, Inc., a Johnson & Johnson Co. directly.
Affected Products
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.
Quantity: 530 units
Why Was This Recalled?
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek, Inc., a Johnson & Johnson Co. has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report