ImplantDirect simply InterActive Implant — Class II medical device recall Z-1917-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-05-30, distributed nationwide. The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
| Recall number | Z-1917-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks, CA, United States |
| Recall initiated | 2018-03-14 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2018-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE, FR, GB, JP, NL |
| Quantity | 298 implants |
| Reason classes | labeling |
| Lot numbers | 68960 |
| Model numbers | 655010U |
Product
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reason for recall
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1917-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.