Reported Dec 18, 2024 · Ongoing

DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm)…

Folsom Metal Products, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Folsom Metal Products, Inc. · 1449 Court Pl · Pelham, AL · 35124-1858

Is this the product you have?

6 of 6 products

Products covered by this recall
Model / numberProduct as published
330.017DKS Large Obturator Trocar ( )
330.011DKS Large Lighted Cannula ( )
DKS Large Kerrison (330.015)
DKS Small Obturator Trocar (330.013)
DKs Small Lighted Cannula (330.014)
DKS Small Kerrison (330.016)
Lot codes and dates
  • Catalog Number DKS-63030
  • Lot Numbers
    • 1560
    • 1567
    • 1578. 4 units were not sent to sterilization
    • therefore were not assigned lot numbers
Amount recalled
42 sets

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Units were not intended for commercial distribution and inadvertently distributed.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.