Z-0650-2025 Class II Ongoing
FDA device recall Z-0650-2025 was initiated by Folsom Metal Products, Inc. on October 30, 2023 and is designated Class II. Reason for recall: Units were not intended for commercial distribution and inadvertently distributed. The recall status is ongoing. Affected quantity: 42 sets.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- October 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 sets
Product Description
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)
Reason for Recall
Units were not intended for commercial distribution and inadvertently distributed.
Distribution Pattern
US distribution to KS, LA, MI, NY, TX.
Code Information
Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.