FDAOctober 30, 2023device

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 (...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Units were not intended for commercial distribution and inadvertently distributed.

What to do

FDA enforcement status: Ongoing

Brands named

folsom metal productsfolsomfolsom metal

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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