Home / Brands / Ivoclar Vivadent
Ivoclar Vivadent Recalls
34 recalls on record · November 27, 2013 to February 14, 2024 · Medical Devices
Recalls by year
13
14
15
16
18
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 14, 2024Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Article No. NA6050411, Valiant PhD No. 1 Econo
Hazard: 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.
February 28, 2018Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Hazard: 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.
February 28, 2018Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Hazard: 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.
February 28, 2018Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Hazard: 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.
February 28, 2018Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Hazard: 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.
December 14, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental i
Hazard: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
December 14, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage
Hazard: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
December 14, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: De
Hazard: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Hazard: 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.
October 12, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Hazard: 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.
August 17, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/P
Hazard: 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.