HIGH

ITS GmbH Recalled 11 Pelvic Reconstruction System PRS Components for MRI Heating Risk (2026)

ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.

Quick Facts at a Glance

Recall Date
January 23, 2026
Hazard Level
HIGH
Brand
I.T.S. GmbH
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact I.T.S. GmbH or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

Pelvic Reconstruction System implants are used in complex pelvic surgeries to restore stability. The two components affected are part of the PRS and are distributed in the US through medical channels.

Why This Is Dangerous

MRI procedures can heat tissue when devices interact with RF energy. The recalled PRS components exhibit higher RF-induced temperature increases than described in the IFU, creating a risk during MRI.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Patients with these implants may need MRI avoidance or modification until cleared. Healthcare facilities should implement recall procedures to identify affected devices and coordinate replacements or monitoring.

Practical Guidance

How to identify if yours is affected

  1. Identify if your device is PRS with article numbers 70312 or 70314.
  2. Check lot numbers: 70312 corresponds to 26/F65133; 70314 corresponds to 86/619736.
  3. If affected, stop using the device immediately and contact a healthcare provider for instructions.
  4. Do not perform MRI or keep the device in MRI environments until cleared by the manufacturer.
  5. Follow the manufacturer's recall instructions and await further guidance on refunds or replacements.

Where to find product info

Recall details are available on the FDA enforcement page linked in the recall notice and through ITS GmbH communications.

What timeline to expect

Timeline for refunds or replacements is not specified in the notice. Await recall communications for next steps.

If the manufacturer is unresponsive

  • Escalate with the healthcare provider or hospital risk management.
  • File a report with FDA recall channels if the manufacturer does not respond timely.

How to prevent similar issues

  • Ask vendors for MRI-compatibility data before implanting hardware.
  • Verify MRI labeling and IFU for implanted devices before MRI procedures.
  • Maintain up-to-date recall monitoring for implanted devices.

Documentation advice

Document all recall communications, keep device labeling and lot numbers, and retain any hospital correspondence related to the recall.

Product Details

Model numbers: 70312 Fixation Screw and 70314 Spike short. Lot numbers: 70312 with 26/F65133; 70314 with 86/619736. Distribution: US nationwide, states include 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, WA. Sold in US nationwide distribution. Price not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 11 units recalled
  • Article numbers 70312 and 70314
  • Lot numbers 26/F65133 and 86/619736
  • MRI safety testing revealed higher RF-induced temperatures under certain MRI conditions
  • Recall status ACTIVE as of 2026-04-01
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURNELECTRICAL

Product Classification

Product TypePelvic Reconstruction System PRS components (Fixation Screw and Spike short)
Sold At
Unknown

Product Details

Model Numbers
1. Article Number (Lot Number): 70312 (26/F65133). 2. Article Number (Lot Number): 70314 (86/619736).
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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