I.T.S. pelvic reconstruction screws heat more in MRI than stated
I.T.S. GmbH is recalling the Pelvic Reconstruction System fixation screw and short spike because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: implanted hardware may heat more during MRI than its instructions state, and no injuries are stated in the source.
Plain-English summary
I.T.S. GmbH is recalling the Pelvic Reconstruction System, covering the fixation screw (article number 70312) and short spike (article number 70314). About 11 units were distributed across 30 US states and territories. The FDA has classified this recall as Class II.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.
Affected product covers article number 70312 (lot 26/F65133) and 70314 (lot 86/619736).
Facilities can identify affected implants by the article and lot numbers above, and may contact I.T.S. GmbH for further information.
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
- Hazard
- mri-heating
- rf-induced-heating
- instructions-understated
Distribution
Distributed nationwide across the United States.
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