Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementati

FDA device recall Z-0915-2012 · posted 2012-01-27 · Terminated

Recall details

Recalling firm

Kerr Corporation

Reason for recall

The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds.

Action taken

Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MZW

Quantity affected

Four hundred and sixty-three (463)

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.

Date initiated

2011-02-03

Date posted

2012-01-27

Date terminated

2012-01-31

Location

Orange, CA

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