Recall Z-0390-2012 ยท EMA Cement, Dental
Henry Schein, Inc.
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
| Date | Jan 11, 2012 (initiated Nov 10, 2011) |
| Status | Terminated |
| Reason | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
| 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 Res |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073209 | MAXCEM 2 Kerr Corporation, Jan 29, 2008 |