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Implant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW
Recalled July 5, 2023 · FDA recall Z-2037-2023 · Implant Direct Sybron Manufacturing
Hazard
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. · FDA Class II
Units
29
Sold at
US Nationwide distribution in the states of FL, ID, TX, CA.
Description
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Product
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;
Manufacturer(s)
Implant Direct Sybron Manufacturing LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →