Prismatik Recalls BruxZir Shaded Dental Restorations Due to Quarantine Failure
Prismatik Dentalcraft is recalling 150 units of BruxZir Shaded dental restorations because the manufacturer failed to properly identify quarantined lots as such.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a procedural failure regarding quarantine of 'at risk' product rather than a confirmed defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Prismatik Dentalcraft, Inc. is recalling 150 units of BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, and 70-1167-NOW0006. These devices are indicated for use by dental technicians in the construction of custom-made all-ceramic restorations for anterior and posterior locations.
The recall was initiated because the new design was manufactured at risk and was supposed to be quarantined and held until validation was completed. Prismatik failed to properly identify these lots as quarantined product. The affected units were distributed nationwide to South Carolina, Minnesota, North Carolina, Indiana, Arizona, Oregon, Washington, California, and Wyoming.
Dental technicians and consumers should check their inventory for the specific model numbers and lot codes listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from whom it was purchased.
The recalled 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
- Prismatik Dentalcraft, Inc
- Affected units
- 150
Distribution
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