FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH Pelvic Reconstruction System recalled for MRI safety concern
What this means
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.
- If you have received one of these implants, contact your surgeon or healthcare provider immediately.
- Before any MRI procedure, inform the MRI facility that you have this device and provide your device documentation.
- Do not undergo MRI until your healthcare provider has reviewed the updated safety information and confirmed it is safe for your specific device.
The agency's original wording
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Intended for
Adults
Illnesses reported
None reported
Sold states
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 count
11 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1600-2026Want us to check the next one for you?
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