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.
Reported: October 5, 2016 Initiated: August 15, 2016 #Z-2897-2016
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.
Details
- Recalling Firm
- Prismatik Dentalcraft, Inc
- Units Affected
- 150 units
- Distribution
- Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
- Location
- Irvine, CA
Frequently Asked Questions
What product 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.. Recalled by Prismatik Dentalcraft, Inc. Units affected: 150 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2897-2016.
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