FDA Medical Device Recalls (openFDA)
Folsom Metal Products, Inc.: 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)
- Recall number
- Z-0650-2025
- Recalling firm
- Folsom Metal Products, Inc.
- Product
- 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)
- Status
- Open, Classified
- Initiated
- 2023-10-30
- Posted
- 2024-12-06
- Terminated
- not on file
- Reason
- Units were not intended for commercial distribution and inadvertently distributed.
- 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: jmartin@frontierdevices.com. 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 jmartin@frontierdevices.com We are available from 9AM to 5PM CST, Monday through Friday.
- Quantity
- 42 sets
- Distribution
- US distribution to KS, LA, MI, NY, TX.
- Lot, serial or model codes
- Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAE
- Firm FEI
- 3006803588
- Firm city
- Pelham
- Firm state
- AL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28