FDAFDA · Food and drugs·Recall number Z-1757-2021
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Published June 9, 2021 · Recall initiated: March 25, 2021
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
Products distributed as sterile may not have been adequately sterilized
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zavation
- Distributor
- US nationwide distribution.
- Lot
- Lot Numbers: 13403ZV, 14172ZV, 13723ZV, 13031ZV, 10760ZV
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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