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Prismatik Dentalcraft, Inc recalls BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The de
Recalled October 5, 2016 · FDA recall Z-2897-2016 · Prismatik Dentalcraft
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. · FDA Class II
Units
150 units
Sold at
Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
Description
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.
Product
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.
Manufacturer(s)
Prismatik Dentalcraft, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →