Small DKS Disposable Kerrison System Inadvertently Distributed
Small DKS Disposable Kerrison System instrument sets were inadvertently distributed when not intended for commercial distribution. Six sets (Lot 1578) were distributed to Kansas, Louisiana, Michigan, New York, and Texas.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is precautionary in nature, addressing inadvertent distribution rather than a documented product defect or identified hazard.
Plain-English summary
Folsom Metal Products, Inc. is recalling the Small DKS Disposable Kerrison System, Catalog Number DKS-63030. The system is a surgical instrument set available in two sizes (3.75mm and 6.35mm), consisting of a Small Obturator Trocar, Small Lighted Cannula, and Small Kerrison.
The units were inadvertently distributed when they were not intended for commercial distribution.
Six sets (Lot Number 1578) were distributed to customers in Kansas, Louisiana, Michigan, New York, and Texas.
The recalled product
- Product
- 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)
- Manufacturer
- Folsom Metal Products, Inc.
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number DKS-63030
- Lot Number: 1578.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Folsom Metal Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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