Class 2 Device Recall Disposable Kerrison System

• Date Initiated by Firm: October 30, 2023
• Date Posted: December 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0650-2025
• Recall Event ID: 95476
• Product Classification: Rongeur, manual - Product Code HAE
• 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)
• Code Information: Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.
• Recalling Firm/ Manufacturer: Folsom Metal Products, Inc. ; 1449 Court Pl; Pelham AL 35124-1858
• For Additional Information Contact: Ms. Jennifer Martin; 205-733-0901
• Manufacturer Reason for Recall: Units were not intended for commercial distribution and inadvertently distributed.
• FDA Determined 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 in Commerce: 42 sets
• Distribution: US distribution to KS, LA, MI, NY, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.