Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation

FDA device recall Z-1076-2013 · posted 2013-04-10 · Terminated

Recall details

Recalling firm

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MZW

Quantity affected

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,

Date initiated

2013-02-22

Date posted

2013-04-10

Date terminated

2014-01-22

Location

Orange, CA

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