FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: 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.
- Recall number
- Z-1962-2019
- Recalling firm
- Zimmer Biomet, Inc.
- 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.
- 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: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825
- 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