# FDA recall Z-0695-2018

> **DePuy Mitek, Inc., a Johnson & Johnson Co.** · Class II · device recall initiated 2017-08-31.

## Product

1113 Gravity Tube Set Pk/24 -SH    Product Usage:  The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

## Reason for recall

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0695-2018
- **Recalling firm:** DePuy Mitek, Inc., a Johnson & Johnson Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-31
- **Report date:** 2018-03-07
- **Termination date:** 2019-04-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2018

## Citation

> AI Analytics. FDA recall Z-0695-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0695-2018. Source: US FDA. Licensed CC0.

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