Class II — Coltene Whaledent Inc
| Recalling firm | Coltene/Whaledent AG |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 |
| Product | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. |
| Quantity | 30 packets |
| Distribution | US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada. |
| Initiated | 2018-08-21 |
| Classified | 2018-11-02 |
| Terminated | 2020-04-10 |
| Recall number | Z-0376-2019 |
| 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 — Coltene Whaledent Inc (Z-0376-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81065/
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