FDAFDA · Food and drugs·Recall number Z-0335-2020
Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
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 products manufactured prior to January 2014.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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