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.
Recall
- Recall Number
- Z-0390-2012
- Event Number
- 60407
- Firm
- Henry Schein, Inc.
- FEI Number
- 1000522050
- Product Code
- EMA
- Status
- Terminated
- Root Cause
- Pending
- Initiated
- November 10, 2011
- Posted
- January 11, 2012
- Terminated
- July 3, 2018
- Address
- 135 Duryea Rd, Melville, NY, 11747
Description
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.
The specific lots of Maxcem Elite Refill Kit appear not to be authentic.
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.
Worldwide distribution: USA (nationwide) and countries of: Bermuda, Martinique FWI, Nassau Bahamas, St Maarten NA, Australia, and South Africa.
18,855 units total: Domestic - 18,820 units; Foreign - 35 units