ImplantDirect — Class II medical device recall Z-0198-2022
Ongoing recall by Implant Direct Sybron Manufacturing LLC, reported 2021-11-10, distributed nationwide. Packaged dental implant contains a different size then the size declared on the labeling.
| Recall number | Z-0198-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing LLC, Westlake Village, CA, United States |
| Recall initiated | 2021-09-23 |
| Classified | 2021-11-03 |
| Reported by FDA | 2021-11-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 83 implants |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10841307101796 |
| Lot numbers | 166300 |
| Model numbers | 834713 |
Product
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Reason for recall
Packaged dental implant contains a different size then the size declared on the labeling.
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-0198-2022. 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.