# FDA recall Z-0705-2022

> **K2M, Inc** · Class II · device recall initiated 2022-01-13.

## Product

Everest MI XT Inner Dilator, Catalog Number 5101-90167

## Reason for recall

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting  together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-0705-2022
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-13
- **Report date:** 2022-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Leesburg, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2022

## Citation

> AI Analytics. FDA recall Z-0705-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0705-2022. Source: US FDA. Licensed CC0.

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