Class II — Implant Direct Sybron Manufacturing, LLC
| Recalling firm | Implant Direct |
|---|---|
| Registered facility | IMPLANT DIRECT SYBRON MANUFACTURING LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. |
| Product | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD |
| Quantity | 151 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan |
| Initiated | 2017-05-02 |
| Classified | 2017-05-22 |
| Terminated | 2018-01-08 |
| Recall number | Z-2125-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Implant Direct Sybron Manufacturing, LLC (Z-2125-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77171/
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