Z-1963-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- June 4, 2019
- Termination Date
- July 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8478 total
Product Description
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - 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.
Reason for Recall
The products do not have sufficient data to support the labeled shelf life of 10 years.
Distribution Pattern
Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
Code Information
Lot Numbers: 211325 209586 210002 210488 210566 210848 210867 210972 211172 211237 212076 212488 212622 212928 212966 214005 214051 214118 214255 214499 214546 214669 214822 214995 215048 215329 215445 215524 215623 216489 216611 217370 217556 217761 217767 218667 219305 219661 219913 220935