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U.S. Department of Health and Human Services

Class 2 Device Recall Maxcem Elite

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  Class 2 Device Recall Maxcem Elite see related information
Date Initiated by Firm November 10, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on July 03, 2018
Recall Number Z-0390-2012
Recall Event ID 60407
510(K)Number K073209  
Product Classification Cement, dental - Product Code EMA
Product Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips

Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent.
Code Information Lot numbers 3285932 (exp. 01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012) ; HSI number 123-7426 
Recalling Firm/
Manufacturer		 Henry Schein, Inc.
135 Duryea Rd
Melville NY 11747
For Additional Information Contact Peter Schmidt
631-454-3003
Manufacturer Reason
for Recall		 The specific lots of Maxcem Elite Refill Kit appear not to be authentic.
FDA Determined
Cause 2		 Pending
Action The firm, Henry Schein, Inc., sent an "URGENT: Product Recall (Dental Practitioners/User Level) letter and response form dated November 10, 2011, via first class mail to its customers. The letter instructed the customers to examine their inventory to verify if they have any of the specified lots on hand. If so, remove it from their shelves. The product may be returned for credit within 30 days, to the following address: Henry Schein, Inc., 41 Weaver Road, Denver, PA 17517. Additionally, the letter instructed the customers to complete, sign, date, and return the enclosed Henry Schein Response Form via fax to: (631) 843-5557 or mail to: Regulatory Affairs Department (E-355) 135 Duryea Road, Melville, NY 11747, Attn: Regulatory-RR. The letter stated "Only returns of the above noted recalled item/lot numbers purchased from Henry Schein, Inc. will be credited to your account. In order to expedite your credit, please include a copy of your response form and invoice, if available, with your return". If you have any questions regarding this matter, please contact Recall Coordinator at 631-390-8000 ext. 8476.
Quantity in Commerce 18,855 units total: Domestic - 18,820 units; Foreign - 35 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Bermuda, Martinique FWI, Nassau Bahamas, St Maarten NA, Australia, and South Africa.
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 = EMA and Original Applicant = KERR CORPORATION
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