FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
- Recall number
- Z-0496-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
- Status
- Terminated
- Initiated
- 2018-10-22
- Posted
- not on file
- Terminated
- 2019-12-11
- Reason
- Label on the outer carton or the patient labels does not match label on the inner sterile packaging
- Root cause
- Labeling mix-ups
- Action
- Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
- Quantity
- 8 units
- Distribution
- AR, MO, MN, NJ, NY, OH, MN , NJ, VA
- Lot, serial or model codes
- Lot Number: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863
- 510(k) numbers
- ["K023546","K113550"]
- 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