Device product
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
Z-0734-2019
Product summary
- Event
- Event 81758
- Status
- Terminated
- Classification
- Class II
- Quantity
- 971 i nTotal
- Official record key
device-enforcement:Z-0734-2019
Official wording
Reason: There is a potential for silicone shedding during cleaning and sterilization.
Code information: Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868
Distribution pattern: Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Derived failure modes
-
Unknown
There is a potential for silicone shedding during cleaning and sterilization.