Skip to content

Vanguard Distal Femoral Augment 75 X 5 RL/LM recallZ-0111-2017 · Zimmer Biomet, Inc. · initiated Aug 9, 2016

Class II Terminated All recalls posted in October 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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].

Recall details

Recall number
Z-0111-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 9, 2016
Posted by the FDA
Oct 18, 2016
Recalling firm
Zimmer Biomet, Inc.
Quantity
5
Product code
JWH
FDA submissions
K023546
Distribution
Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.

Product description

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.

Code information (models, lots, serial numbers)

Item Number 184108 Lot Number 183410 Exp. 8/27/2025

Other devices under the same FDA submission

52 devices cleared under K023546 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page