Quick Facts at a Glance
- Recall Date
- January 23, 2026
- Hazard Level
- HIGH
- Brand
- I.T.S. GmbH
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- I.T.S. GmbH
- Product type
- Pelvic Reconstruction System implants and components
- Model numbers
- 1. Article Number (Lot Numbers): 21218-16 (679/112166, 679/122229, 679/122230, 679/122304), 21219-16 (679/012441, 679/062456, 679/0624561, 679/112167 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 23, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The ITS Pelvic Reconstruction System is a modular orthopedic implant set used to treat pelvic fractures and reconstruct pelvic anatomy. It includes plates, screws, and related fixation components. Surgeons select specific configurations based on fracture pattern and anatomy.
Why This Is Dangerous
MRI exposure can cause RF-induced heating of implanted hardware. Under certain MRI conditions, the temperature rise may be higher than the IFU describes, creating a risk to surrounding tissue.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
The recall could disrupt planned surgeries or follow-up MRIs. Patients with the device should avoid MRI until cleared and coordinate with their healthcare team for refunds or replacements.
Practical Guidance
How to identify if yours is affected
- Review device labeling for article numbers listed in the recall.
- Compare your implant components to the article numbers in the recall summary.
- Check packaging and IFU for MRI safety specifications.
Where to find product info
Identifiers are located on device labeling and packaging. Article numbers appear in the IFU and the recall listing. The FDA recall page provides the official dataset.
What timeline to expect
Not specified in the recall; refunds or replacements will be issued per ITS instructions and may require coordination with healthcare providers.
If the manufacturer is unresponsive
- Escalate to your hospital’s risk management or patient safety office.
- Consider filing a complaint with the FDA if there is delayed resolution.
- Consult a medical attorney if you experience complications or the vendor is unresponsive.
How to prevent similar issues
- Verify MRI compatibility and safety with implanted devices before scheduling scans.
- Ask surgeons and radiologists to confirm MRI protocol compatibility with the specific implant.
- Keep up to date with manufacturer recalls and product alerts.
Documentation advice
Keep copies of recall notices, labeling, article numbers, MRI history, and all correspondence with ITS and healthcare providers.
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Product Details
Product family: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix). 46,637 units recalled. Nationwide US distribution. Article numbers include numerous plate and screw components as listed in the recall summary.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 46,637 units recalled nationwide in the US
- Multiple device families affected including Anterior/Posterior Column Plates, Quadrilateral Buttress
- RF-induced heating risk during MRI under certain conditions
- No injuries or incidents reported to date
- Follow recall instructions for refunds or replacements
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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