FDAFDA · Food and drugs·Recall number Z-0651-2025
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)
Published December 18, 2024 · Recall initiated: October 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Units were not intended for commercial distribution and inadvertently distributed.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Folsom Metal Products, Inc.
- Distributor
- US distribution to KS, LA, MI, NY, TX.
- Lot
- Catalog Number DKS-63030, Lot Number: 1578.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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