Data Foundry

Medical device recalls 2020

Legacy 3 Implant — Class II medical device recall Z-1041-2020

Terminated recall by Implant Direct Sybron Manufacturing LLC, reported 2020-02-12, distributed nationwide. Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

Recall numberZ-1041-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmImplant Direct Sybron Manufacturing LLC, Westlake Village, CA, United States
Recall initiated2019-10-07
Classified2020-02-05
Reported by FDA2020-02-12
Terminated2021-04-28
DistributedNationwide (US)
Quantity72
Lot numbers83327
Model numbers864213

Product

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Reason for recall

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

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-1041-2020. 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.