# FDA recall Z-1697-2021

> **K2M, Inc** · Class II · device recall initiated 2021-05-07.

## Product

Cascadia AN Interbody Convex   10x28x14mm  Catalog Number: 6101-2102814NC-G2    Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.

## Reason for recall

Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

## Distribution

Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.

## Key facts

- **Recall number:** Z-1697-2021
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-07
- **Report date:** 2021-06-09
- **Termination date:** 2023-03-08

- **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-1697-2021

## Citation

> AI Analytics. FDA recall Z-1697-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1697-2021. Source: US FDA. Licensed CC0.

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