Device product
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Z-2533-2017
Product summary
- Event
- Event 77277
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,939 units total (870 units in US)
- Official record key
device-enforcement:Z-2533-2017
Official wording
Reason: Due to possibility of insufficient sterilization.
Code information: CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)
Distribution pattern: US and worldwide: Australia, Finland, France, United Kingdom
Derived failure modes
-
Sterility assurance
insufficient sterilization