# FDA recall Z-2207-2020

> **Nobel Biocare Usa Llc** · Class II · device recall initiated 2019-07-19.

## 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.

## Distribution

US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV,  NY, OK, PA, SC, SD, TX, UT, WA, WI    OUS: None

## Key facts

- **Recall number:** Z-2207-2020
- **Recalling firm:** Nobel Biocare Usa Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2020-06-10
- **Termination date:** 2020-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yorba Linda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2020

## Citation

> AI Analytics. FDA recall Z-2207-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2207-2020. Source: US FDA. Licensed CC0.

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