Class I - Dangerous
Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
Ivoclar Vivadent
34 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Infusion Pumps
Class I - Dangerous
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Class I - Dangerous
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Class I - Dangerous
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Class I - Dangerous
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Class I - Dangerous
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Class I - Dangerous
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Class I - Dangerous
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
Class I - Dangerous
Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.
A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
Class I - Dangerous
Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.