Recall Weekly
Moderate riskFDA DeviceClass II

I.T.S. GmbH Pelvic Reconstruction System recalled for MRI safety concern

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.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have received one of these implants, contact your surgeon or healthcare provider immediately.
  2. Before any MRI procedure, inform the MRI facility that you have this device and provide your device documentation.
  3. Do not undergo MRI until your healthcare provider has reviewed the updated safety information and confirmed it is safe for your specific device.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 17 products — see all of them.

Details

Units affected
11 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1600-2026

In the FDA's words

Description
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314. Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). 1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736). Distribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. Affected quantity: 11 units
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

17 products in this recall

I.T.S. bone plates and screws recalled for MRI heating risk

I.T.S. is recalling 17 orthopedic implant product lines, including bone plates and screw systems. Updated MRI safety testing found that these implants can heat up more during certain MRI conditions than the product instructions previously stated. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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