FDA recall Z-2037-2023

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;

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.

Key facts

Status

Ongoing

Initiation date

2023-05-02

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2037-2023