Recall Z-1963-2019
Zimmer Biomet, Inc. · initiated June 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
Reason for recall
The products do not have sufficient data to support the labeled shelf life of 10 years.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.
Details
- Recall number
- Z-1963-2019
- Initiated
- June 4, 2019
- Terminated
- July 21, 2021
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Quantity
- 8478 total
- Distribution
- Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1962-2019 Class II | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with…The products do not have sufficient data to support the labeled shelf life of 10 years. | 06/04/2019Terminated |