FDAFDA · Food and drugs·Recall number Z-2897-2016
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Published October 5, 2016 · Recall initiated: August 15, 2016
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
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Prismatik Dentalcraft, Inc
- Distributor
- Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
- Lot
- BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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