# FDA recall Z-1064-2019

> **Keystone Dental Inc** · Class II · device recall initiated 2019-02-22.

## Product

Paltop 1.25 Hex Drivers, Short  Part  Number:  60-70102

## Reason for recall

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

## Distribution

FL, MA, SC, VA

## Key facts

- **Recall number:** Z-1064-2019
- **Recalling firm:** Keystone Dental Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-22
- **Report date:** 2019-04-03
- **Termination date:** 2020-06-19

- **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-1064-2019

## Citation

> AI Analytics. FDA recall Z-1064-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1064-2019. Source: US FDA. Licensed CC0.

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