Device 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)
Z-0650-2025
Product summary
- Event
- Event 95476
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42 sets
- Official record key
device-enforcement:Z-0650-2025
Official wording
Reason: Units were not intended for commercial distribution and inadvertently distributed.
Code information: Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.
Distribution pattern: US distribution to KS, LA, MI, NY, TX.
Derived failure modes
-
Unknown
Units were not intended for commercial distribution and inadvertently distributed.