Device product
Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
Z-0850-2014
Product summary
- Event
- Event 66832
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 cases (10 units per case = 550 units)
- Official record key
device-enforcement:Z-0850-2014
Official wording
Reason: Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
Code information: Lot M3085K301 and M2327K301
Distribution pattern: US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX.
Derived failure modes
-
Unknown
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.