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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 Posting Updated 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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