Legacy SMARTbase, NERecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Legacy SMARTbase, NE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of Legacy SMARTbase, NE by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Legacy SMARTbase, NE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 2, 2023Open, Classified
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Z-2037-2023 · Root cause: No Marketing Application · names 4 of these models · Recall details · FDA record ↗
Legacy SMARTbase, NE models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Legacy™ SMARTbase, NE 8730-81NEAbutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, NE 8730-82NEAbutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, NE 8735-82NEAbutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, NE 8745-82NEAbutment, Implant, Dental, Endosseous1 recall0 reports
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- Legacy2 Implant78 models · 8,257 reports · 2 recalls
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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