Device product
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)
Z-0651-2025
Product summary
- Event
- Event 95476
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 sets
- Official record key
device-enforcement:Z-0651-2025
Official wording
Reason: Units were not intended for commercial distribution and inadvertently distributed.
Code information: Catalog Number DKS-63030, Lot Number: 1578.
Distribution pattern: US distribution to KS, LA, MI, NY, TX.
Derived failure modes
-
Unknown
Units were not intended for commercial distribution and inadvertently distributed.