# FDA recall Z-2580-2023

> **Keystone Industries** · Class II · device recall initiated 2023-04-10.

## Product

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material  KI Item No.: 0921940HS  Henry Schein Item No.: 570-0718

## Reason for recall

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

## Distribution

US Nationwide distribution in the states of IL, PA, FL  NV, TX.

## Key facts

- **Recall number:** Z-2580-2023
- **Recalling firm:** Keystone Industries
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-10
- **Report date:** 2023-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gibbstown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2023

## Citation

> AI Analytics. FDA recall Z-2580-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2580-2023. Source: US FDA. Licensed CC0.

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