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I.T.S. GmbH recalls Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw;
Recalled April 1, 2026 · FDA recall Z-1600-2026 · I.T.S
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). · FDA Class II
Units
11 units
Sold at
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.
Description
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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.
Manufacturer(s)
I.T.S. GmbH
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →