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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 Posted April 10, 2013
Recall Status1 Terminated 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
714-516-7400
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MZW and Original Applicant = KERR CORPORATION
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