Z-2897-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2016
- Initiation Date
- August 15, 2016
- Termination Date
- December 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units
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.
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.
Distribution Pattern
Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
Code Information
BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614