Every recall we track for I.T.S. GmbH — 18 in all — plus the complaints and injury reports the public filed about them.
I.T.S. GmbH recalls Pelvic Reconstruction System (PRS) with specific fixation screws due to higher MRI temperature risks than previously stated in instructions.
I.T.S. GmbH recalls Volar Radius Plate PROlock II due to potential MRI safety risks from RF-induced temperature increases. Affected models include specific article numbers and lot numbers.
I.T.S. GmbH recalls specific Pilonplate models due to potential MRI safety risks from RF-induced temperature increases. Affected units include certain anterolateral tibia plates and pilon plates with specific article numbers.
I.T.S. GmbH recalls FR.O.H. Calc: Anterolateral Calcaneus Plate (Article 21064-60) due to potential MRI temperature increases. Affected units sold with specific lot numbers.
I.T.S. recalls DUL and UOL surgical systems due to potential MRI heating risks. Updated MRI safety testing shows higher RF temperature increases than previously stated in instructions.
I.T.S. recalls certain Humeral Head Plates with Angular Stability due to potential MRI safety risks. Updated MRI testing shows higher RF temperature increases than previously stated in instructions.
I.T.S. GmbH recalls Claviculaplate with Angular Stability due to potential MRI safety risks from RF-induced temperature increases. Affected models include specific article numbers and lot ranges.
I.T.S. recalls certain Fibula Plate PROlock models due to potential MRI safety risks. Updated MRI testing shows higher RF temperature increases than previously stated in instructions.
I.T.S. recalls specific orthopedic plates (DFL and PTL models) due to MRI safety risks. Updated testing shows these implants can cause higher temperature increases during MRI scans than previously stated, potentially leading to burns.
I.T.S. GmbH - 212141-7, 212141-8, 212151-7, 212151-8, 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7, 21208-13, 21209-13, 21208-11, 21209-11, 212061-10, 212061-14, 212071-10, 212071-14, 211751-5, 211771-4, 211821-10, 211821-11, 211821-12, 211821-14, 21161-4, 21161-6, 211621-4, 211621-6, 211631-6, 211631-8
I.T.S. Straight Plate with Angular Stability models may cause unsafe temperature increases during MRI scans. Affected units include specific forearm and straight plates with listed article numbers and lot numbers.
I.T.S. GmbH recalls certain Distal Humeral Plates with Angular Stability due to potential MRI heating risks. Updated MRI safety testing shows higher RF-induced temperature increases than previously stated in instructions.
Recall of I.T.S. Hand Locking Plates System components due to potential MRI safety risks from RF-induced temperature increases. Affected items include specific cortical screws and plates with listed article numbers.
I.T.S. GmbH recalls specific screw and washer models due to updated MRI safety testing showing higher RF-induced temperature increases than previously stated in instructions.
I.T.S. GmbH recalls Olecranonplate with Angular Stability due to potential MRI safety risks from RF-induced temperature increases. Affected models include specific article numbers and lot numbers.
I.T.S. GmbH recalls foot locking plates systems due to potential MRI safety risks from higher RF-induced temperature increases than previously stated in instructions.
I.T.S. recalls headless compression screws with higher MRI temperature risks. Updated MRI testing shows potential for RF-induced heating during scans. Affected models include specific article numbers and lot numbers.
I.T.S. GmbH recalls Rim Plate, 10-Hole, Left, PRS RX System with incorrect laser marked article number. This implant stabilizes bone temporarily until consolidation. Affected units have model 21206-10 and lot 26/F42778.
