I.T.S. GmbH: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 703
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- I.T.S. GmbH
- 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.
- Reason / hazard
- Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
- Classification
- Class II
- Status
- Ongoing
- Distribution / 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.
- Recall initiated
- 2026-01-23
- Code info
- 1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
- Product quantity
- 11 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lasnitzhohe
- Country
- Austria
- Event id
- 98341
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