Temporary Snap Abutment Engaging CC RP 1 — Class II medical device recall Z-1857-2020
Terminated recall by Nobel Biocare Usa Llc, reported 2020-05-13, distributed nationwide. Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed th
| Recall number | Z-1857-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nobel Biocare Usa Llc, Yorba Linda, CA, United States |
| Recall initiated | 2019-08-09 |
| Classified | 2020-05-04 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 478 units |
| UPC / GTIN / UDI-DI | 07332747115604 |
| Lot numbers | 13077550, 13077551 |
| Model numbers | 38761 |
Product
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Reason for recall
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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-1857-2020. 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.