FDAFDA · Food and drugs·Recall number Z-0723-2021
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Published December 30, 2020 · Recall initiated: December 1, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.
- Lot
- Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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