# FDA recall Z-0650-2025

> **Folsom Metal Products, Inc.** · Class II · device recall initiated 2023-10-30.

## Product

DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing:  1. DKS Large Obturator Trocar (Model Number 330.017)  2. DKS Large Lighted Cannula (Model Number 330.011)  3. DKS Large Kerrison (330.015)  4. DKS Small Obturator Trocar (330.013)  5. DKs Small Lighted Cannula (330.014)  6. DKS Small Kerrison (330.016)

## Reason for recall

Units were not intended for commercial distribution and inadvertently distributed.

## Distribution

US distribution to KS, LA, MI, NY, TX.

## Key facts

- **Recall number:** Z-0650-2025
- **Recalling firm:** Folsom Metal Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-30
- **Report date:** 2024-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pelham, AL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2025

## Citation

> AI Analytics. FDA recall Z-0650-2025. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0650-2025. Source: US FDA. Licensed CC0.

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