I.T.S

I.T.S. GmbH has recalled certain plates and screws used in pelvic reconstruction surgery because new testing shows they may heat up more than expected during MRI scans under certain conditions. This was not fully described in the original instructions. No injuries have been reported.

I.T.S. GmbH has recalled certain cortical screws, locking stabilization screws, and HLS plates used in hand surgery. New MRI safety testing found these implants may heat up more than expected during MRI scans under certain conditions. The original instructions did not reflect this updated safety information.

I.T.S. GmbH headless compression screws used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated. This affects specific lot numbers of these implants distributed across the United States.

I.T.S. GmbH has recalled certain foot locking plates and hallux osteotomy locking plates used in orthopedic surgery. New MRI safety testing found that these implants may heat up more than expected during MRI scans under certain conditions, which was not fully described in the original instructions.

I.T.S. GmbH is recalling specific DUL and UOL bone plate and screw systems used to stabilize ulna fractures. New MRI safety testing found these implants generate more heat during MRI scans than the original instructions stated, which could potentially cause tissue damage.

I.T.S. GmbH recalled certain distal femur and tibia locking plates used in orthopedic surgery after updated MRI safety testing found they produce higher temperature increases during MRI scans than the original instructions stated. This could potentially cause tissue heating at the implant site during an MRI procedure.

I.T.S. GmbH distal humeral plates and locking cortical screws used in arm surgery may heat more than expected during MRI scans under certain conditions. New testing found the heating levels are higher than what the original instructions stated.

I.T.S. GmbH fibula plates used in orthopedic surgery have been recalled because new MRI safety testing found they heat up more than the instructions originally stated when exposed to certain MRI machine conditions. This could potentially cause tissue burns during an MRI scan.

I.T.S. GmbH has recalled certain Pelvic Reconstruction System components (Fixation Screws and Spike short devices) because updated MRI safety testing found they may heat up more than expected during MRI scans under certain conditions. The original instructions did not fully reflect these temperature increases.

I.T.S. GmbH surgical screws (cannulated cancellous screws, cortical screws, and washers) used in orthopedic surgery can heat up more than expected during MRI scans under certain conditions. New safety testing found the temperature increases are higher than what was stated in the device instructions.

I.T.S. GmbH orthopedic plates used in bone surgery were tested for safety during MRI scans. Testing found these plates can get hotter than originally stated when exposed to certain MRI conditions. The manufacturer has updated safety information to reflect the actual heating levels.

I.T.S. GmbH olecranon plates and olecranon hook plates used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated.

I.T.S. GmbH has recalled certain Pilonplate devices used in orthopedic surgery because new MRI safety testing found they heat up more than expected during MRI scans under certain conditions. The devices affected include Anterolateral Tibia Plates, Pilon Plates 4mm, and Pilon Plates Small with specific article and lot numbers.

I.T.S. GmbH's FR.O.H. Calcaneus Repair System (anterolateral calcaneus plate, Article Number 21064-60) may heat more than expected during MRI scans under certain conditions. New testing found higher radiofrequency-induced temperature increases than the original instructions stated. Only 4 units were distributed nationwide.

I.T.S. GmbH issued a recall for certain Humeral Head Plate with Angular Stability implants used in shoulder surgery. Testing found the device may heat up more than expected during MRI scans under certain conditions. The product labeling did not reflect these updated safety findings.

I.T.S. GmbH clavicle plates used in shoulder surgery may heat up more than expected during MRI scans under certain conditions. New testing found higher temperature increases than the original instructions stated. This affects specific article numbers and lot numbers distributed across the US.

I.T.S. GmbH's Radius Plate PROlock II (a surgical implant for wrist fractures) has been recalled because new MRI safety testing found the device heats up more than the instructions said it would under certain MRI scanner conditions. The original safety information in the product labeling did not reflect these higher temperature increases.