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 | Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant |
| Product | REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 |
| Quantity | 60 units |
| Distribution | CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland |
| Initiated | 2018-05-18 |
| Classified | 2018-07-05 |
| Terminated | 2020-07-13 |
| Recall number | Z-2376-2018 |
| 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-2376-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80281/
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