Z-0495-2019Class II

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Name: Z-0495-2019 Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Creator: Zimmer Biomet, Inc.
Published: 2018-10-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-10-22 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 on 2018-10-22. FDA classified it as Class II and gives the reason as "Label on the outer carton or the patient labels does not match label on the inner sterile packaging". 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-0495-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Posted: 2018-11-21
Terminated: 2019-12-11
Recalling firm: Zimmer GmbH
Product: Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Root cause tag: labeling and UDI
FDA 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 in commerce: 8 units
Distribution: AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Product codes and lots: Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0495-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0495-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-21
Z-0496-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-21

Product code JWH

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)