ImplantDirect — Class II medical device recall Z-2551-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-08-01, distributed in AZ, CA, CO, CT, FL, ID, IL, NC…. The main vial label lists the incorrect part number, but the cap label is correct.
| Recall number | Z-2551-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks, CA, United States |
| Recall initiated | 2017-03-03 |
| Classified | 2018-07-26 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2018-08-06 |
| Distributed | AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, WA |
| Countries outside the US | CH, DE, ES, LT |
| Quantity | 124 units |
| Reason classes | labeling |
| Lot numbers | 87837 |
Product
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reason for recall
The main vial label lists the incorrect part number, but the cap label is correct.
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-2551-2018. 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.