FDA Device recall Z-2207-2020
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 by Nobel Biocare Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2207-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nobel Biocare Usa |
| Distribution | 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 |
Product
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Reason
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.
Identifiers
| code_info | Lot number: 13080792 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2020%22
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