Implant Direct Sybron Manufacturing LLC: 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 SMARTBA

Hazard

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

Details from the source

Reason for recall: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. Distribution: US Nationwide distribution in the states of FL, ID, TX, CA. Quantity: 29 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;

UPC codes

10841307123002, 10841307123019, 10841307123026, 10841307123064, 10841307123033, 10841307123071

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.