Product Wiki · Recalls · U.S. FDA — Device Enforcement

BruxZir Shaded, Model No — recall Z-2897-2016

U.S. FDA — Device Enforcement · United States · 2016-08-15 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2897-2016
Date of alert
2016-08-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Prismatik Dentalcraft, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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