Z-0650-2025 Class II Ongoing
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.