FDA-Device2024-12-18Class II
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)
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
42 sets
Manufactured in
1449 Court Pl, Pelham, AL, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2025Don't want to check this manually?
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