Z-0673-2018Class II

Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442

Name: Z-0673-2018 Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442
Creator: Zimmer Biomet, Inc.
Published: 2017-09-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-09-29 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty on 2017-09-29. FDA classified it as Class II and gives the reason as "Knee implant components (tibial bearings) are labeled with the incorrect size". 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-0673-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-29
Posted: 2018-02-21
Terminated: 2019-04-17
Recalling firm: Zimmer GmbH
Product: Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Knee implant components (tibial bearings) are labeled with the incorrect size.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Zimmer Biomet sent an Urgent Medical Device Recall letter dated September 29, 2017 to their customers. The letter identified the affected product, problems and actions to be taken. Customers were instructed to remove the affected product from inventory and provide to their Zimmer sales representative or, if the consignee is a distributor, to ship the affected product back to Zimmer. Consignees were also asked to complete a recall response form and send this back to the firm. Returns are being physically destroyed. If you have further questions 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. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 24
Distribution: Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
Product codes and lots: Lot Number: 388680, Exp. Date 5/19/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0673-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0673-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21
Z-0674-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code JWH

K023546Class IIMaxim Accel Knee SystemBiomet, Inc. / cleared 2003-01-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)