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Vanguard Knee System recallZ-0937-2019 · Zimmer Biomet, Inc. · initiated Dec 21, 2018

Terminated

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

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

FDA root cause category: Under Investigation by firm

What the company is doing

Zimmer Biomet conduct this recall to distributors and hospital risk managers that have unconsumed consigned inventory or inventory within their territory. Distributors notified via email on 12/21/18. Hospital risk managers, as well as distributors with product, will be notified via courier. Distributors issued letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors to return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. Questions or concerns after reviewing notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

Recall details

Recall number
Z-0937-2019
Status
Terminated
Initiated by the company
Dec 21, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
45 units
Product code
JWH
FDA submissions
K040770
Distribution
MN, VA Foreign: Korea, New Zealand and Japan

Product description

Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764

Code information (models, lots, serial numbers)

Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

16 devices cleared under K040770 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 82004).

Sources and updates

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