Z-1011-2018Class II

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Name: Z-1011-2018 Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Creator: Zimmer Biomet, Inc.
Published: 2017-10-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-10-03 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty on 2017-10-03. FDA classified it as Class II and gives the reason as "The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur". 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-1011-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Posted: 2018-03-14
Terminated: 2018-08-23
Recalling firm: Zimmer GmbH
Product: Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form via digital copy to: [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: [email protected] "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in commerce: 8
Distribution: US Distribution to states of: FL, WI, MD, MO, and MI.
Product codes and lots: Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1011-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1011-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

Product code MBH

K113550Class IIVanguard Complete Knee SystemBiomet Manufacturing Corp / cleared 2012-02-29

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)