Implant Direct — Class II medical device recall Z-0364-2020
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2019-11-20, distributed in IN, MD, TX, VA, WA. A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant orde
| Recall number | Z-0364-2020 |
|---|---|
| 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 | 2019-08-09 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2021-04-27 |
| Distributed | IN, MD, TX, VA, WA |
| Countries outside the US | JP |
| Quantity | 23 implants |
| Lot numbers | 135128 |
| Model numbers | 833708 |
| Expiration dates | 2020-03-12 |
Product
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Reason for recall
A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
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-0364-2020. 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.