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U.S. Department of Health and Human Services

Class 2 Device Recall Kerr Maxcem Elite

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  Class 2 Device Recall Kerr Maxcem Elite see related information
Date Initiated by Firm February 22, 2013
Date Posted April 10, 2013
Recall Status1 Terminated 3 on January 22, 2014
Recall Number Z-1076-2013
Recall Event ID 64559
510(K)Number K073209  
Product Classification Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
Product Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0.

Used for cementation of all indirect restorations.
Code Information 34417 KIT- MAXCEM ELITE INTRO 2-4662052 4672087 4694484 4698107 4710901 4719936 4725775 4725776 34418 KIT - MAXCEM ELITE BULK-4706738 4656479 4656480 4666810 4666811 4666813 4668612 4709788 4710900 4712887 4725780 4729919 4734053 4744195 SYRINGE LOT NUMBERS 34417 & 34418 SYRINGE- MAXCEM ELITE CLEAR Individually affected syringes within Kits listed above-4663716 4663717 4690551 4690552 4704821 4728088 4741721 33872 REFILL- MAXCEM ELITE CLEAR-4664825 4669840 4669841 4672089 4676812 4676815 4678974 4678975 4690548 4690549 4690550 4702597 4710904 4710905 4718097 4720553 4720555 4720558 4720560 4720562 4720563 4720564 4720565 33873 REFILL- MAXCEM ELITE WHITE-4681749 4699954 4704804 4720556 4720567 4720568 4720569 4720573 4720574 4720575 33874 -REFILL- MAXCEM ELITE WHITE OPAQUE-4720576 4720577 4720578 4720579 4720580 33875-REFILL- MAXCEM ELITE YELLOW -4652147 4696832 4720198 33876 -REFILL- MAXCEM ELITE BROWN -4710907 4725879 34055 MAXCEM ELITE STANDARD KIT-4620128 4656894 4680372 4709328 4728932 4732387 4733719 4735545 4748933 4759314 34056 -MAXCEM ELITE VALUE KIT-4719214 4759315 4698814 34057 -MAXCEM ELITE MINI KIT-4709329 4714775 4728934 4732388 4756503 34058 MAXCEM ELITE REFILL CLEAR-4628189 4728840 4728844 4728935 4730842 4732144 4735257 4735546 4748934 4756504 34059 -MAXCEM ELITE REFILL WHITE-4705713 4728936 4745082 4756505 34060 MAXCEM ELITE REFILL WHITE OPAQUE-4719215 4735547 4768408 34061 MAXCEM ELITE REFILL YELLOW -4700948 4705714 4728937 4756506 4768409 34062 MAXCEM ELITE REFILL BROWN -4709330 4738886 4749728 MAXCEM ELITE CLEAR FILLED SYRINGE-4679149 4679150 4681816 4681817 4685882 4685882 4694026 4694026 4694028 4694030 4708393 4708393 4717716 4721155 4733694 4741330 4756672 4756673 4766817 MAXCEM ELITE WHITE OPAQUE FILLED SYRINGE -4684879 4685879 4733678 MAXCEM ELITE YELLOW FILLED SYRINGE -4689433 4689433 4693134 4693134 4717719 4743042 4770898 MAXCEM ELITE BROWN FILLED SYRINGE -4708392
Recalling Firm/
Manufacturer		 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer Reason
for Recall		 Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Kerr Corporation/Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 22, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers are instructed to determine if you have any of the affected products in your inventory; If you have the affected lots, please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number for quick return; complete and return the Maxcem Elite Acknowledgement and Recall Return Form via fax to 714-288-4609 regardless of whether you have any product in your inventory. If you are an authorized Kerr Corporation distributor, identify and contact those customers that may have been shipped the affected product within 48 hours of receipt of this field correction notification. If you have any question, contact Kerr Customer Care at 1-800-537-7123.
Quantity in Commerce 40,819 kit and syringe units
Distribution Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.
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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