# FDA recall Z-2828-2020

> **NOBEL BIOCARE SERVICES AG** · Class II · device recall initiated 2020-07-20.

## 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.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of  Albania and Hong Kong.

## Key facts

- **Recall number:** Z-2828-2020
- **Recalling firm:** NOBEL BIOCARE SERVICES AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-20
- **Report date:** 2020-08-26
- **Termination date:** 2021-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kloten, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2828-2020

## Citation

> AI Analytics. FDA recall Z-2828-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2828-2020. Source: US FDA. Licensed CC0.

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