DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) con
Summary
The FDA issued a Class II for DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that c by Folsom Metal Products, Inc.. Reason: Units were not intended for commercial distribution and inadvertently distributed..
Details
Source
Device Recall
External ID
Z-0650-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.
Quantity Affected: 42 sets
Reason for Recall
Units were not intended for commercial distribution and inadvertently distributed.
Distribution
US distribution to KS, LA, MI, NY, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-30
Company
Pelham, AL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Folsom Metal Products, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Folsom Metal Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Folsom Metal Products, Inc. have FDA actions?
Folsom Metal Products, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0650-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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