Reported Dec 30, 2020 · Terminated

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item…

Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • Vanguard 360 Revision System Posterior
  • Augment With Bolt - Product Usageintended for
  • use in knee arthroplasty Item Number185422
Lot codes and dates
  • Lot Number098780
  • UDI Number(01) 00880304482739 (17) 290501 (10) 098780
Amount recalled
21 units

Where it was sold

  • Nationwide
  • FL

Why it was recalled

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2022 · Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.