Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 5, 2016
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.
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. Prismati…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Prismatik Dentalcraft, Inc recalled BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0… - a moderate-severity action.
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0… was recalled by Prismatik Dentalcraft, Inc in October 5, 2016. Reason: Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to…. Check the official notice for the remedy. Verify recall #Z-2897-2016 with the FDA Devices before acting.
The recall
Prismatik Dentalcraft, Inc issued this moderate-severity FDA Devices recall-Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to….
- Moderate
- severity level
- 150 units
- affected scope
- Class II
- classification
- October 5, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2897-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2897-2016) was formally reported on October 5, 2016, with the manufacturer initiating the action on August 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Prismatik Dentalcraft, Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 150 units.
The documented reason for this recall is: 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 a… Distribution data in the federal record shows the product reached: Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
150 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2897-2016 |
| Date reported | October 5, 2016 |
| Date initiated | August 15, 2016 |
| Recalling firm | Prismatik Dentalcraft, Inc |
| Firm location | Irvine, CA |
| Affected scope | 150 units |
| Distribution | Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2897-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2897-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 5, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.