FDAFDA · Food and drugs·Recall number Z-1631-2021
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Published May 26, 2021 · Recall initiated: March 22, 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 labeled as sterile were distributed, but may not have been sterilized.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- BIOPSYBELL S.R.L.
- Distributor
- US Nationwide distribution in the states MS and KY.
- Lot
- BATCH: 19123253
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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