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 | packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. |
| Product | Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant |
| Quantity | 53 implants |
| Distribution | US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO, |
| Initiated | 2018-10-26 |
| Classified | 2019-11-12 |
| Recall number | Z-0363-2020 |
| 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-0363-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83794/
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