medical Class II Updated 2023-07-05

Implant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMAR

Recalled 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;

Hazard / Issue

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: REF/UDI-DI/Lot: 8730-81NE/10841307123002/92637, 131309; 8730-82NE/10841307123019/92638, 163063; 8735-80NNE/10841307123026/160542; 8735-82NE/10841307123064/15002360; 8745-80NNE/10841307123033/15004780; 8745-82NE/10841307123071/182029;

View official government recall

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