Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX Recalled by Synthes (USA) Products LLC Due to Products not sterilized, sterility cannot be confirmed
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
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Quantity: 5 units
Why Was This Recalled?
Products not sterilized, sterility cannot be confirmed
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