FDAFDA · Food and drugs·Recall number Z-0084-2021
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Published October 14, 2020 · Recall initiated: September 4, 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
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
- Lot
- Lot Numbers: 894660A 894660B 894670B 894700B
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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