Prismatik Dentalcraft, Inc recalls BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The devic…

Recall date

August 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2897-2016

FDA classification

Class II

Brand / firm

Prismatik Dentalcraft, Inc

Sold / distributed

Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.