# FDA recall Z-0110-2020

> **K2M, Inc** · Class II · device recall initiated 2018-07-24.

## Product

YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA  3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm,  4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm,  4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm)    Catalog Numbers 7601-03512, 7601-03514,  7601-03532, 7601-03534,  7601-03538L, 7601-03540L,  7601-04016L, 7601-04018L,  7601-04020L, 7601-04022L,  7601-04024L, 7601-04026L,  7601-04028L, 7601-04030,  7601-05022, 7601-05028,  7601-05030

## Reason for recall

Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.

## Distribution

Distributed to accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, and WA.. Foreign distribution to Australia.

## Key facts

- **Recall number:** Z-0110-2020
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-24
- **Report date:** 2019-10-16
- **Termination date:** 2020-10-01

- **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-0110-2020

## Citation

> AI Analytics. FDA recall Z-0110-2020. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0110-2020. Source: US FDA. Licensed CC0.

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