LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 — Class II medical device recall Z-2425-2020
Ongoing recall by Zest Anchors LLC, reported 2020-07-01, distributed nationwide. The abutment provided with the Implant System may be out of specification, which could lead to a small gap occ
| Recall number | Z-2425-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zest Anchors LLC, Carlsbad, CA, United States |
| Recall initiated | 2019-11-22 |
| Classified | 2020-06-23 |
| Reported by FDA | 2020-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, MX, PL, TH |
| Quantity | 154 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00840481101496, 00840481101526, 00840481101571, 00840481101595, 00840481126116 |
| Lot numbers | L15H7, L15H9, L166F, L17MB, L17VE, LL5PB |
Product
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Reason for recall
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
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-2425-2020. 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.