Z-0651-2025 Class II Ongoing

Recalled by Folsom Metal Products, Inc. — Pelham, AL

Recall Details

Product Type
Devices
Report Date
December 18, 2024
Initiation Date
October 30, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 sets

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)

Reason for Recall

Units were not intended for commercial distribution and inadvertently distributed.

Distribution Pattern

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

Code Information

Catalog Number DKS-63030, Lot Number: 1578.