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 | Ongoing |
| Reason | Packaged dental implant contains a different size then the size declared on the labeling. |
| Product | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, |
| Quantity | 83 implants |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan. |
| Initiated | 2021-09-23 |
| Classified | 2021-11-03 |
| Recall number | Z-0198-2022 |
| 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-0198-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88859/
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