Recall Z-0651-2025 ยท HAE Rongeur, Manual
Folsom Metal Products, Inc.
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)
| Date | Dec 6, 2024 (initiated Oct 30, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 6 sets |
| Distribution | US distribution to KS, LA, MI, NY, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.