# FDA recall Z-1853-2020

> **Nobel Biocare Usa Llc** · Class II · device recall initiated 2019-08-09.

## Product

Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - 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.

## Reason for recall

Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.

## Key facts

- **Recall number:** Z-1853-2020
- **Recalling firm:** Nobel Biocare Usa Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-09
- **Report date:** 2020-05-13
- **Termination date:** 2021-12-01

- **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-1853-2020

## Citation

> AI Analytics. FDA recall Z-1853-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1853-2020. Source: US FDA. Licensed CC0.

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