U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
원인
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 work¿time thereby causing the product to prematurely set by 15 seconds.
조치
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 work¿time 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.
Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
제품 설명
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