FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
- Recall number
- Z-0937-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
- Status
- Terminated
- Initiated
- 2018-12-21
- Posted
- not on file
- Terminated
- 2020-05-13
- Reason
- Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
- Root cause
- Under Investigation by firm
- Action
- Zimmer Biomet conduct this recall to distributors and hospital risk managers that have unconsumed consigned inventory or inventory within their territory. Distributors notified via email on 12/21/18. Hospital risk managers, as well as distributors with product, will be notified via courier. Distributors issued letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors to return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. Questions or concerns after reviewing notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday
- Quantity
- 45 units
- Distribution
- MN, VA Foreign: Korea, New Zealand and Japan
- Lot, serial or model codes
- Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960
- 510(k) numbers
- ["K040770"]
- PMA numbers
- not on file
- Product code
- JWH
- 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