Class II

Medical Device Recall: Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Sma

Folsom Metal Products, Inc. · October 30, 2023

Reason for Recall

Units were not intended for commercial distribution and inadvertently distributed.

Product Description

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

Distribution

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

States Affected

KS, LA, MI, NY, TX

Quantity Affected

6 sets

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0651-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Folsom Metal Products, Inc. Medical Device Recall: Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Sma | SafeCheck