Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 Recalled by Synthes (USA) Products LLC Due to Drill Pin (drill bit) is not compatible with...
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
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Quantity: 191 units
Why Was This Recalled?
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
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