Implant Direct Sybron Manufacturing LLC: Medical Device Recall in 2023 - (Recall #: Z-2037-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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;

Product Classification:

Class II

Date Initiated: May 2, 2023

Date Posted: July 5, 2023

Recall Number: Z-2037-2023

Event ID: 92415

Reason for Recall:

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

Status: Ongoing

Product Quantity: 29

Code Information:

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;

Distribution Pattern:

US Nationwide distribution in the states of FL, ID, TX, CA.

Voluntary or Mandated:

Voluntary: Firm initiated