Z-0390-2012

Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR...

Name: Z-0390-2012 Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR...
Creator: Henry Schein, Inc.
Published: 2011-11-10
License: https://open.fda.gov/license/

Henry Schein, Inc. / initiated 2011-11-10 / Terminated

FDA source

Henry Schein, Inc. began a recall of 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... on 2011-11-10. The reason FDA records is "The specific lots of Maxcem Elite Refill Kit appear not to be authentic". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0390-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2012-01-11
Terminated: 2018-07-03
Recalling firm: Henry Schein, Inc.
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.
Product code: EMA Cement, Dental
Reason for recall: The specific lots of Maxcem Elite Refill Kit appear not to be authentic.
FDA root cause: 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.
Product codes and lots: Lot numbers 3285932 (exp. 01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012) ; HSI number 123-7426

Product code EMA

K073209Class IIMaxcem 2Kerr Corporation / cleared 2008-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)