Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ImplantDirect simply RePlant Implant Recalled by Implant Direct Sybron Manufacturing, LLC Due to The incorrect device was packaged in the vial.
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 RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Quantity: 158 devices
Why Was This Recalled?
The incorrect device was packaged in the vial.
Where Was This Sold?
This product was distributed to 17 states: AL, AZ, CA, CO, CT, FL, GA, ID, IL, KY, MD, MA, NV, NM, NY, PA, TX
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