I.T.S. GmbH Recalls

17 recalls found for I.T.S. GmbH. Check if any of your products are affected.

HIGHFDA DEVICE

I.T.S. Screw System Recalled for MRI Heating Risk in 5,568 Units (2026)

I.T.S. GmbH has recalled 5,568 units of the I.T.S. Screw System sold nationwide in the United States after MRI safety tests showed higher RF-induced temperature increases under some MRI conditions than the IFU outlined. The defect involves MRI RF heating that could burn patients. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS GmbH Recalled 510 I.T.S Straight Plate with Angular Stability Over MRI Heating Risk (2026)

ITS GmbH recalled 510 units of the I.T.S Straight Plate with Angular Stability after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The recall covers multiple article numbers across forearm and straight plates and distributions nationwide in the United States. No injuries or incidents have been reported at this time. Healthcare providers andpatients

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. GmbH LRS Orthopedic System Recall: 176 Units for MRI Heating Risk (2026)

ITS GmbH recalled 176 units nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The issue could cause burns during MRI exposure. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. Volar Radius Plate PROlock II Recall 220 Units for MRI Heating Risk (2026)

I.T.S. GmbH recalled 220 Volar Radius Plate PROlock II devices after updated MRI safety testing showed higher RF-induced temperatures under certain MRI conditions. The devices were distributed nationwide in the United States. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS GmbH Recalled 11 Pelvic Reconstruction System PRS Components for MRI Heating Risk (2026)

ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. FR.O.H. Calcaneus Plate Recalled for MRI Heating Risk in 4 Units (2026)

I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate, 4 units, distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS Fibula Plate PROlock with Angular Stability Recall Affects 869 Units (2026)

ITS recalls 869 Fibula Plate PROlock with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Hospitals and healthcare providers should stop using this device immediately and follow the recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. GmbH Claviculaplate with Angular Stability Recalled for MRI Heating Risk 322 Units (2026)

I.T.S. GmbH recalled 322 Claviculaplate with Angular Stability devices sold nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU reflected. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. Pelvic Reconstruction System Recall for MRI Heating Risk (46,637 Units) 2026

I.T.S. recalled 46,637 pelvic reconstruction system components nationwide in the United States after MRI safety testing showed higher RF-induced heating than the IFU stated. The issue centers on MRI heating under certain conditions that could injure patients. Patients should stop using the devices and follow manufacturer recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. GmbH Recalls 15,517 FLS Foot Locking Plates System and Hallux Osteotomy Plates Over MRI Heat‑

I.T.S. GmbH recalled 15,517 FLS Foot Locking Plates System and HOL Hallux Osteotomy locking plates distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Patients and healthcare providers should stop using this device immediately and follow the recall instructions from:

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS Recalls 70 Olecranon Plates Over MRI RF Heating Risk (2026)

ITS recalls 70 Olecranon Plates with Angular Stability distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using this device immediately and contact ITS or their healthcare provider for instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS GmbH Recalls 623 HCS Headless Cannulated Screws Over MRI Heating Risk (2026)

ITS GmbH recalled 623 HCS Headless Cannulated Screws distributed nationwide to U.S. healthcare facilities. The defect involves higher RF-induced temperature increases during certain MRI procedures than the IFU described. Affected patients and providers should stop using immediately and follow recall instructions. Contact ITS GmbH or your healthcare provider for instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS GmbH HLS Hand Locking Plates System Recalled for MRI Heating Risk (1,307 Units, 2026)

ITS GmbH recalled 1,307 units of the HLS Hand Locking Plates System distributed nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases. The issue exceeds what is described in the IFU under certain MRI conditions. Patients and healthcare providers should stop using the device immediately and follow ITS GmbH's recall instructions.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

ITS GmbH Humeral Head Plate MRI Recall Affects 292 Units in 2026

ITS GmbH recalled 292 proximal humeral plates nationwide in the United States after MRI safety testing showed higher RF-induced heating under certain MRI conditions. The heating can occur during MRI and may cause burns or tissue damage. Patients and clinicians should stop using the device immediately and follow the recall instructions from ITS GmbH and their healthcare providers.

I.T.S. GmbH
Updated MRI
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HIGHFDA DEVICE

I.T.S. Ulna Locking Plate Systems Recalled Over MRI Heating Risk (2026)

I.T.S. GmbH recalled 120 units of its DUL and UOL ulna locking plate systems distributed nationwide to U.S. healthcare providers after MRI safety testing showed higher RF-induced heating. The updated testing found temperature increases under certain MRI conditions not reflected in the Instructions for Use. Healthcare facilities and patients should stop using the devices immediately and follow the厂

I.T.S. GmbH
Updated MRI
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Brand Statistics

Total Recalls
17
Pages
1