FDA-Device2024-12-18Class II
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)
Folsom Metal Products, Inc.
Hazard
Units were not intended for commercial distribution and inadvertently distributed.
Sold states
US distribution to KS, LA, MI, NY, TX.
Affected count
6 sets
Manufactured in
1449 Court Pl, Pelham, AL, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0651-2025Don't want to check this manually?
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