NobelReplace Conical Connection — Class II medical device recall Z-2828-2020
Terminated recall by NOBEL BIOCARE SERVICES AG, reported 2020-08-26, distributed nationwide. Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements ar
| Recall number | Z-2828-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOBEL BIOCARE SERVICES AG, Kloten, N/A, Switzerland |
| Recall initiated | 2020-07-20 |
| Classified | 2020-08-20 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2021-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Quantity | 188 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07332747073584 |
| Lot numbers | 13084072 |
| Model numbers | 37291 |
Product
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Reason for recall
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
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-2828-2020. 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.