Prismatik Dentalcraft, Inc: Medical Device Recall in 2016 - (Recall #: Z-2897-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 15, 2016

Date Posted: October 5, 2016

Recall Number: Z-2897-2016

Event ID: 75082

Reason for Recall:

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.

Status: Terminated

Product Quantity: 150 units

Code Information:

BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated