Device product
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Z-1962-2019
Product summary
- Event
- Event 83085
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8478 total
- Official record key
device-enforcement:Z-1962-2019
Official wording
Reason: The products do not have sufficient data to support the labeled shelf life of 10 years.
Code information: Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825
Distribution pattern: Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Derived failure modes
-
Unknown
The products do not have sufficient data to support the labeled shelf life of 10 years.