Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
DePuy Spine
36 recalls • • Categories: Other Medical Devices, Implants & Prosthetics, Infusion Pumps, Surgical Instruments
Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
Class I - Dangerous
Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
Class I - Dangerous
Device does not mate as intended.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Class I - Dangerous
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Class I - Dangerous
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Class I - Dangerous
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Class I - Dangerous
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
Class I - Dangerous
A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.