Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DePuy Synthes 8.0 mm Flexible Shaft Reamer Recalled by Synthes (USA) Products LLC Due to Devices did not pass the biological safety evaluation...
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
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Quantity: 244 units
Why Was This Recalled?
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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