NobelReplace Conical Connection RP 4 — Class II medical device recall Z-0658-2022
Terminated recall by Nobel Biocare Usa Llc, reported 2022-03-02, distributed nationwide. Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the
| Recall number | Z-0658-2022 |
|---|---|
| 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 | 2021-12-17 |
| Classified | 2022-02-18 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2024-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, TR |
| Quantity | 702 units |
| UPC / GTIN / UDI-DI | 07332747160529 |
| Lot numbers | 13116495, 13116496, 13116497 |
| Model numbers | 36707 |
Product
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Reason for recall
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
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-0658-2022. 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.