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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Related recalls
Same manufacturer · Prismatik Dentalcraft, Inc
See all →- ModerateSilent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2026-07-29
- HighDental implant screws recalled because the wrong screw was packaged
FDA (Devices) · 2025-11-12
- ModerateGlidewell HT Implant Twist Drill recalled due to packaging mix-up
FDA (Devices) · 2025-06-04
Similar recalls
- HighZimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation
FDA (Devices) · 2019-07-24
- ModerateZimmer Manufacturing Recalls Sterile Bone Fixation Appliances Due to Calibration Issues
FDA (Devices) · 2016-03-23
- HighCustomized Brius orthodontic devices recalled for design control failure
FDA (Devices) · 2022-04-13
- HighZimmer Air Dermatome Recalled for Broken Planetary Gear Teeth
FDA (Devices) · 2013-06-12
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
- HighBaxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure
FDA (Devices) · 2021-09-08