FDAHealthJanuary 23, 2026
I.T.S. GmbH — 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).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 23, 2026
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.
What's affected?
- 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.
- Brand
- I.T.S. GmbH
- Lot code
- ):
Additional details
1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11 units.
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