Z-0915-2012

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

Name: Z-0915-2012 Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is...
Creator: Kerr Corporation
Published: 2011-02-03
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2011-02-03 / Terminated / root cause: manufacturing process

FDA source

Kerr Corporation began a recall of Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations... on 2011-02-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0915-2012
Status: Terminated
Initiated: 2011-02-03
Posted: 2012-01-27
Terminated: 2012-01-31
Recalling firm: Sybron Dental Specialties, Inc.
Product: Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
Product code: MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: Four hundred and sixty-three (463)
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
Product codes and lots: Lot Number 3360900

Product code MZW

K073209Class IIMaxcem 2Kerr Corporation / cleared 2008-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)