Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LEGACY SMARTBASE Recalled by Implant Direct Sybron Manufacturing LLC Due to Non-engaging abutments were distributed without FDA clearance; the...
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
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
Quantity: 29
Why Was This Recalled?
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
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 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report