Z-0938-2019Class II

Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

Name: Z-0938-2019 Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Creator: Zimmer Biomet, Inc.
Published: 2018-12-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-12-21 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 on 2018-12-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0938-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-02-23
Terminated: 2020-05-13
Recalling firm: Zimmer GmbH
Product: Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 90 units
Distribution: MN, VA Foreign: Korea, New Zealand and Japan
Product codes and lots: Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0937-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-23
Z-0938-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-23

Product code JWH

K171054Class IIBiomet Knee Joint Replacement ProsthesesBiomet, Inc. / cleared 2017-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)