LEGACY SMARTBASE — Class II medical device recall Z-2037-2023
Ongoing recall by Implant Direct Sybron Manufacturing LLC, reported 2023-07-05, distributed nationwide. Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet be
| Recall number | Z-2037-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing LLC, Westlake Village, CA, United States |
| Recall initiated | 2023-05-02 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
| UPC / GTIN / UDI-DI | 10841307123002, 10841307123019, 10841307123026, 10841307123033, 10841307123064, 10841307123071 |
| Lot numbers | 131309, 163063, 8730-81NE/10841307123002/92637, 8730-82NE/10841307123019/92638 |
| Model numbers | 8730-81NE, 8730-82NE, 8735-80NNE, 8735-82NE, 8745-80NNE, 8745-82NE |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2037-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.