# FDA recall Z-1268-2021

> **CARESTREAM DENTAL, LLC** · Class II · device recall initiated 2021-02-15.

## Product

Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

## Reason for recall

The mirror may become detached and fall from the unit

## Distribution

Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ,  OK, IN and the country of Canada.

## Key facts

- **Recall number:** Z-1268-2021
- **Recalling firm:** CARESTREAM DENTAL, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-15
- **Report date:** 2021-03-24
- **Termination date:** 2023-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2021

## Citation

> AI Analytics. FDA recall Z-1268-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1268-2021. Source: US FDA. Licensed CC0.

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