DKS Kerrison System (Folsom) – unauthorized distribution (2023)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Units were not intended for commercial distribution and inadvertently distributed.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

KS, LA, MI, NY, TX