Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. Due to Product is incorrectly labeled. The blade configuration in...
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
FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Quantity: 50 units
Why Was This Recalled?
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Where Was This Sold?
This product was distributed to 5 states: DE, ME, MI, OH, TX
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