ImplantDirect Legacy 4 Implant — Class II medical device recall Z-1920-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-05-30, distributed in FL, GA, MD, MI, NC, NY, OR, TX…. The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap wa
| Recall number | Z-1920-2018 |
|---|---|
| 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 | 2016-11-15 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2018-06-04 |
| Distributed | FL, GA, MD, MI, NC, NY, OR, TX, UT, VA |
| Quantity | 18 units |
| Reason classes | labeling |
| Lot numbers | 71729 |
| Model numbers | 5.7MMD, 855708, 885708 |
Product
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Reason for recall
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
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-1920-2018. 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.