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 | Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label. |
| Product | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure. |
| Quantity | 217 units |
| Distribution | Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia. |
| Initiated | 2018-05-29 |
| Classified | 2018-10-09 |
| Terminated | 2020-07-29 |
| Recall number | Z-0089-2019 |
| 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-0089-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80297/
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