# FDA recall Z-1009-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-10-25.

## Product

fastener, fixation, nondegradable, soft tissue

## Reason for recall

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

## Distribution

TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

## Key facts

- **Recall number:** Z-1009-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-25
- **Report date:** 2018-03-21
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2018

## Citation

> AI Analytics. FDA recall Z-1009-2018. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/Z-1009-2018. Source: US FDA. Licensed CC0.

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