# FDA recall Z-2037-2023

> **Implant Direct Sybron Manufacturing LLC** · Class II · device recall initiated 2023-05-02.

## 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

- **Recall number:** Z-2037-2023
- **Recalling firm:** Implant Direct Sybron Manufacturing LLC
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2037-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2037-2023. Source: US FDA. Licensed CC0.

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