# FDA recall Z-1511-2018

> **Synthes, Inc.** · Class II · device recall initiated 2018-03-05.

## Product

Flex Arm    Product Usage:  The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.

## Reason for recall

Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.

## Distribution

Worldwide distribution - US Nationwide and the countries of  Canada, Switzerland and Japan

## Key facts

- **Recall number:** Z-1511-2018
- **Recalling firm:** Synthes, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-05
- **Report date:** 2018-05-02
- **Termination date:** 2019-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2018

## Citation

> AI Analytics. FDA recall Z-1511-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1511-2018. Source: US FDA. Licensed CC0.

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