FDA Device recall Z-2037-2023
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE by Implant Direct Sybron Manufacturing, citing non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2037-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-02 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
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
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Identifiers
| code_info | REF/UDI-DI/Lot: 8730-81NE/10841307123002/92637, 131309; 8730-82NE/10841307123019/92638, 163063; 8735-80NNE/108413071230…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing - Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing
All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2037-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.