Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synapse System 3.5mm TI Cancellous Polyaxial Screws Recalled by Synthes (USA) Products LLC Due to The subject product measures 4.0mm in diameter instead...
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 Synthes (USA) Products LLC directly.
Affected Products
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Quantity: 6
Why Was This Recalled?
The subject product measures 4.0mm in diameter instead of 3.5mm.
Where Was This Sold?
This product was distributed to 1 state: NJ
About Synthes (USA) Products LLC
Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report