NobelActive Internal NP 3 — Class II medical device recall Z-2207-2020
Terminated recall by Nobel Biocare Usa Llc, reported 2020-06-10, distributed in AL, AR, AZ, CA, CO, CT, FL, HI…. The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may cont
| Recall number | Z-2207-2020 |
|---|---|
| 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 | 2019-07-19 |
| Classified | 2020-06-02 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2020-10-27 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MI, MO, MS, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI |
| Quantity | 221 implants |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07332747010619 |
| Lot numbers | 13080792 |
| Model numbers | 34128 |
Product
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Reason for recall
The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
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-2207-2020. 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.