Implant Direct — Class II medical device recall Z-1157-2020
Terminated recall by Implant Direct Sybron Manufacturing LLC, reported 2020-02-19, distributed in AR, AZ, CA, GA, ID, IL, IN, KY…. Through a customer complaint and and internal investigation it was determined that some implant packages conta
| Recall number | Z-1157-2020 |
|---|---|
| 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 | 2019-10-11 |
| Classified | 2020-02-12 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2024-04-12 |
| Distributed | AR, AZ, CA, GA, ID, IL, IN, KY, MD, MO, ND, NH, NJ, NV, NY, OR, PA, TX, UT, WA, WI, WV |
| Quantity | 78 implants |
| Lot numbers | 68209 |
| Model numbers | 855710 |
Product
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Reason for recall
Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.
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-1157-2020. 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.