# FDA recall Z-0104-2022

> **K2M, Inc** · Class II · device recall initiated 2021-09-08.

## Product

Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068

## Reason for recall

Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.

## Distribution

Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.

## Key facts

- **Recall number:** Z-0104-2022
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-08
- **Report date:** 2021-10-20
- **Termination date:** 2024-05-17

- **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-0104-2022

## Citation

> AI Analytics. FDA recall Z-0104-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0104-2022. Source: US FDA. Licensed CC0.

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