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U.S. Department of Health and Human Services

Class 2 Device Recall Maxcem Elite, a dental cement

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  Class 2 Device Recall Maxcem Elite, a dental cement see related information
Date Initiated by Firm February 03, 2011
Date Posted January 27, 2012
Recall Status1 Terminated 3 on January 31, 2012
Recall Number Z-0915-2012
Recall Event ID 60685
510(K)Number K073209  
Product Classification Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
Product Brand name: Maxcem Elite,
Product: a dental cement,
Part Number: 34418.


The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
Code Information Lot Number 3360900
Recalling Firm/
Manufacturer		 Kerr Corporation
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer Reason
for Recall		 The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.
Quantity in Commerce Four hundred and sixty-three (463)
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
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 = MZW and Original Applicant = KERR CORPORATION
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