Recall Z-0915-2012 ยท MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Kerr Corporation
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
| Date | Jan 27, 2012 (initiated Feb 3, 2011) |
| Status | Terminated |
| Reason | 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 | 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 con |
| Quantity | Four hundred and sixty-three (463) |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073209 | MAXCEM 2 Kerr Corporation, Jan 29, 2008 |