# FDA recall Z-2250-2020

> **Nobel Biocare Usa Llc** · Class II · device recall initiated 2019-05-28.

## Product

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

## Reason for recall

Packaged dental implant healing abutments were found to contain the wrong size device.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY.    The countries of AT, RU, BE, DE, GB, NO, PL, PT.

## Key facts

- **Recall number:** Z-2250-2020
- **Recalling firm:** Nobel Biocare Usa Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2020-06-10
- **Termination date:** 2021-02-09

- **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-2250-2020

## Citation

> AI Analytics. FDA recall Z-2250-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2250-2020. Source: US FDA. Licensed CC0.

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