FDAFDA · Food and drugs·Recall number Z-0298-2020
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100
Published November 13, 2019 · Recall initiated: October 10, 2019
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
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Distributed nationwide.
- Lot
- All product manufactured prior to January 2014.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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