Z-0651-2025Class II

Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes...

Name: Z-0651-2025 Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes...
Creator: Folsom Metal Products, Inc.
Published: 2023-10-30
License: https://open.fda.gov/license/

Folsom Metal Products, Inc. / initiated 2023-10-30 / Open, Classified

FDA source

Folsom Metal Products, Inc. began a recall of 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... on 2023-10-30. FDA classified it as Class II and gives the reason as "Units were not intended for commercial distribution and inadvertently distributed". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0651-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-30
Posted: 2024-12-06
Recalling firm: Folsom Metal Products, Inc.
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)
Product code: HAE Rongeur, Manual
Reason for recall: Units were not intended for commercial distribution and inadvertently distributed.
FDA root cause: No Marketing Application
Action: Folsom Metal Products, Inc. d/b/a Frontier Devices, initially notified consignees via telephone during November 2023. An "URGENT: MEDICAL DEVICE RECALL" letter dated 11/8/2024 was sent to consignees on about 11/08/2024. Consignees were instructed to complete and return the Medical Device Recall Response Acknowledgement and Receipt form to document receipt of and understanding of the recall, as well as reconciliation of affected units. Immediately examine your inventory and quarantine any product remaining in your possession that is subject to this recall. If you are in possession of product that is subject to this recall, please return the product by mail to: Frontier Devices at 1449 Court Place, Pelham, AL 35124; Fax to: (205)733-8445 or email: [email protected]. If you no longer have product in your inventory, but destroyed the recalled product, please complete the enclosed Certificate of Destruction Form in addition to the Medical Device Recall Return Response Acknowledgment and Receipt form. If you have any questions, please contact Jennifer Martin at (205) 733-0901 or by email at [email protected] We are available from 9AM to 5PM CST, Monday through Friday.
Quantity in commerce: 6 sets
Distribution: US distribution to KS, LA, MI, NY, TX.
Product codes and lots: Catalog Number DKS-63030, Lot Number: 1578.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0651-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0650-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-06
Z-0651-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-06

Product code HAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)