Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ImplantDirect simply InterActive Implant Recalled by Implant Direct Sybron Manufacturing, LLC Due to The cap on the vial might be labeled...
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 Implant Direct Sybron Manufacturing, LLC directly.
Affected Products
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Quantity: 298 implants
Why Was This Recalled?
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Implant Direct Sybron Manufacturing, LLC
Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report