FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: 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.
- Recall number
- Z-1963-2019
- Recalling firm
- Zimmer Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-06-04
- Posted
- not on file
- Terminated
- 2021-07-21
- Reason
- The products do not have sufficient data to support the labeled shelf life of 10 years.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers.
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K031280"]
- PMA numbers
- not on file
- Product code
- JDX
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28