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, PREGNANT, ELDERLY
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
- Orthopedic plate set (I.T.S. Straight Plate with Angular Stability)
- Model numbers
- 1. Article Number (Lot Numbers): 21604-6 (643/052301, 643/0652, 643/092201), 21604-9 (643/032311, 643/062308, 643/062309, 643/112310, 643/122201). 2. Article Number (Lot Numbers): 21605-11 (643/072314 +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
Orthopedic plates used to stabilize forearm fractures in surgical procedures. They come in multiple thicknesses and configurations, designed to be fixed to bone with screws.
Why This Is Dangerous
MRI exposure can cause heating of the implanted plate due to RF energy. This heating could pose a burn risk to surrounding tissue.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The devices may require discontinuation of use and consultation with a clinician. Patients may need alternative stabilization methods or adjusted imaging plans.
Practical Guidance
How to identify if yours is affected
- Identify if your device is among the recalled article numbers.
- Consult your surgeon or orthopedic specialist for confirmation.
Where to find product info
Refer to the manufacturer's recall notice and your device labeling for article numbers. Contact ITS GmbH via email for official instructions.
What timeline to expect
Official recall remediation timeline not specified. Follow manufacturer instructions and clinician guidance.
If the manufacturer is unresponsive
- Document all communications.
- Escalate to the hospital’s risk management or patient safety office if the manufacturer is slow to respond.
How to prevent similar issues
- If purchasing implants in the future, verify MRI compatibility and safety testing in the IFU.
- Consult clinicians about MRI safety before imaging.
- Maintain copies of all recall communications and instructions.
Documentation advice
Keep the recall notice, correspondence with the manufacturer, and your clinician's guidance. Record article numbers and imaging plans.
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Product Details
Product line: I.T.S Straight Plate with Angular Stability Distribution: US nationwide Units recalled: 510 Categories: Forearm Plate, Forearm Plate Curved, Forearm Plate Straight, Straight Compression Plate, Straight Plate (1.5mm, 2.0mm, 3.5mm, 4.5mm) Article numbers affected: 21604-6, 21604-9, 21605-11, 21605-6, 21605-9, 21105-6, 21105-8, 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9, 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13, 21102-6, 21103-8, 21103-11, 21103-10, 21103-12, 21103-13, 21103-8, 21103-9 Reason for recall: Updated MRI safety testing demonstrateshigher
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MRI safety testing updated showing higher RF heating
- Multiple article numbers across forearm and straight plates
- Distributed nationwide in the US and territories
- No injuries reported to date
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Safety Guide
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