Universal Base CC RP 1 — Class II medical device recall Z-1856-2020
Terminated recall by Nobel Biocare Usa Llc, reported 2020-05-13, distributed nationwide. Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot
| Recall number | Z-1856-2020 |
|---|---|
| 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 | 238 units |
| UPC / GTIN / UDI-DI | 07332747096538 |
| Lot numbers | 13076822 |
| Model numbers | 38214 |
Product
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - 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 (universal base) 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-1856-2020. 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.