[pending] Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.
Pending LLM rewrite. Source: FDA_DEVICE Z-1600-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
The recalled product
- 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
- I.T.S. GmbH
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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