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

FDA device recall Z-0650-2025 · posted 2024-12-06 · Open, Classified

Recall details

Recalling firm

Folsom Metal Products, Inc.

Reason for recall

Units were not intended for commercial distribution and inadvertently distributed.

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

HAE

Quantity affected

42 sets

Distribution

US distribution to KS, LA, MI, NY, TX.

Date initiated

2023-10-30

Date posted

2024-12-06

Location

Pelham, AL