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
| Model / number | Product as published |
|---|---|
330.017 | DKS Large Obturator Trocar ( ) |
330.011 | DKS 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
156015671578. 4 units were not sent to sterilizationtherefore 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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