Legacy SMARTbase, Narrow, NERecalls & reported problems across all models

We found 2 models of Legacy SMARTbase, Narrow, 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, Narrow, 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.

1. 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 2 of these models · Recall details · FDA record ↗

Legacy SMARTbase, Narrow, NE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Legacy™ SMARTbase, Narrow, NE 8735-80NNE

  Abutment, Implant, Dental, Endosseous
  1 recall0 reports
• Legacy™ SMARTbase, Narrow, NE 8745-80NNE

  Abutment, Implant, Dental, Endosseous
  1 recall0 reports

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