ITS Pelvic Reconstruction System MRI Safety Class II Recall
Summary
FDA has issued a Class II recall for I.T.S. GmbH's Pelvic Reconstruction System following updated MRI safety testing that demonstrates higher RF-induced temperature increases under certain MRI conditions than previously documented in the Instructions for Use. Affected products include the Fixation Screw (Article Number 70312) and Spike short (Article Number 70314). The recall is ongoing with US nationwide distribution across multiple states.
What changed
FDA has issued a Class II medical device recall for I.T.S. GmbH's Pelvic Reconstruction System following updated MRI safety testing that demonstrates higher RF-induced heating risks under certain MRI conditions than previously reflected in the Instructions for Use. The affected products are the Fixation Screw (Article Number 70312) and Spike short (Article Number 70314), distributed nationwide across multiple US states.
Healthcare providers and manufacturers should immediately review MRI safety protocols for patients implanted with these devices and obtain updated safety information from I.T.S. GmbH. The discrepancy between current testing data and IFU documentation creates immediate patient safety considerations that require prompt clinical review and potential modification of MRI procedures for affected patients.
What to do next
- Review MRI safety protocols for patients with ITS Pelvic Reconstruction System implants
- Contact I.T.S. GmbH for updated MRI safety information and revised Instructions for Use
- Monitor for FDA and manufacturer updates regarding this recall
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
I.T.S. GmbH
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1600-2026 · 20260401 · Ongoing
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 for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distribution
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...
Source: openFDA Enforcement API
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