Implant Direct — Class II medical device recall Z-0363-2020
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2019-11-20, distributed in AK, AR, AZ, CA, CO, FL, ID, IL…. packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged i
| Recall number | Z-0363-2020 |
|---|---|
| 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 | 2018-10-26 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Distributed | AK, AR, AZ, CA, CO, FL, ID, IL, KS, MN, NC, NV, NY, OH, TX, UT, VA |
| Quantity | 53 implants |
| Lot numbers | 120197, 120198 |
| Model numbers | 654311U |
| Expiration dates | 2023-07-16, 2023-07-19 |
Product
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Reason for recall
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
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-0363-2020. 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.