ImplantDirect Legacy 3 Implant — Class II medical device recall Z-0018-2020
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2019-10-09, distributed nationwide. Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
| Recall number | Z-0018-2020 |
|---|---|
| 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 | 2018-08-08 |
| Classified | 2019-10-01 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2019-10-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA |
| Quantity | 22 vials |
| Reason classes | labeling |
| Lot numbers | 110350 |
| Model numbers | 855216 |
Product
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are 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
Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
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-0018-2020. 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.