Z-0111-2017Class II

Vanguard Distal Femoral Augment 75 X 5 RL/LM

Name: Z-0111-2017 Vanguard Distal Femoral Augment 75 X 5 RL/LM
Creator: Zimmer Biomet, Inc.
Published: 2016-08-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-08-09 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic... on 2016-08-09. FDA classified it as Class II and gives the reason as "Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes...". 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-0111-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Posted: 2016-10-18
Terminated: 2017-05-17
Recalling firm: Zimmer GmbH
Product: Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a call back the next business day. Alternatively, your questions may be sent by email to [email protected].
Quantity in commerce: 5
Distribution: Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.
Product codes and lots: Item Number 184108 Lot Number 183410 Exp. 8/27/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0111-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17

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)