ImplantDirect simply RePlant Implant — Class II medical device recall Z-0010-2020
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2019-10-09, distributed in AL, AZ, CA, CO, CT, FL, GA, ID…. The incorrect device was packaged in the vial.
| Recall number | Z-0010-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2018-08-07 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, ID, IL, KY, MA, MD, NM, NV, NY, PA, TX |
| Countries outside the US | AE, DE, ES, GB, IT, TT |
| Quantity | 158 devices |
| UPC / GTIN / UDI-DI | 10841307108313 |
| Lot numbers | 108191 |
| Model numbers | 604313U |
Product
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason for recall
The incorrect device was packaged in the vial.
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-0010-2020. 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.