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FDAJanuary 23, 2026device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

What to do

FDA enforcement status: Ongoing

Brands named

i t s

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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