# FDA recall Z-1358-2018

> **Aesculap Implant Systems LLC** · Class III · device recall initiated 2018-02-16.

## Product

Doyen-Collin Mouth Gag 120MM/ General Instruments

## Reason for recall

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

## Distribution

nationwide

## Key facts

- **Recall number:** Z-1358-2018
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-16
- **Report date:** 2018-04-18
- **Termination date:** 2020-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2018

## Citation

> AI Analytics. FDA recall Z-1358-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1358-2018. Source: US FDA. Licensed CC0.

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