# FDA recall Z-1179-2018

> **Keystone Dental Inc** · Class III · device recall initiated 2017-10-16.

## Product

STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

## Reason for recall

A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

## Distribution

International Distribution to: Germany only.

## Key facts

- **Recall number:** Z-1179-2018
- **Recalling firm:** Keystone Dental Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-16
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2018

## Citation

> AI Analytics. FDA recall Z-1179-2018. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1179-2018. Source: US FDA. Licensed CC0.

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