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U.S. Department of Health and Human Services

Class 2 Device Recall BruxZir Shaded

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  Class 2 Device Recall BruxZir Shaded see related information
Date Initiated by Firm August 15, 2016
Create Date September 27, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall Number Z-2897-2016
Recall Event ID 75082
510(K)Number K130924  
Product Classification Powder, porcelain - Product Code EIH
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.
Code Information BZ0004415  BZ0004745  BZ0004416  BZ0004747  BZ0004522  BZ0004360  BZ0004496  BZ0004593  BZ0004094  BZ0004614  
Recalling Firm/
Manufacturer		 Prismatik Dentalcraft, Inc
2181 Dupont Dr
Irvine CA 92612-1301
For Additional Information Contact
949-440-2600
Manufacturer 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.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action Prismatik DentalCraft, Inc. sent an Urgent Medical Device Recall letter dated August 15, 2016, to all their customers to inform them that Prismatik Dentalcraft is recalling BruxZir NOW product 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 the implicated lots as quarantined product. Customers are informed that the BruxZir Now with the thicker sprue design was packaged and shipped to customers in error. Customers are informed of that there is no risk to the patient and of the actions to be taken for the customers and from Prismatic Dentalcraft Inc. For questions regarding this recall call 949-440-2600.
Quantity in Commerce 150 units
Distribution Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EIH and Original Applicant = PRISMATIK DENTALCRAFT, INC.
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