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
- Orthopedic Locking Reconstruction System
- Model numbers
- 1. Article Number (Lot Numbers): 21301-5 (26/F62569), 21301-7 (26/F62570), 21301-9 (26/F67518), 21301-13 (26/F62568, 26/F67815), 21302-5 (26/F67520), 21302-7 (26/F67821), 21302-9 (26/F62572 +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 I.T.S. LRS is an orthopedic implant system used in complex knee and leg reconstructions. It includes distal femur and tibia locking plates used in fracture repair.
Why This Is Dangerous
The device may experience higher RF-induced heating during MRI, which can cause tissue damage or burns in the area of the implant.
Industry Context
This recall is not described as part of a broader industry pattern in the document.
Real-World Impact
The recall requires immediate cessation of use. Patients with the device should avoid MRI unless cleared. The recall may affect surgical planning and postoperative imaging for affected patients.
Practical Guidance
How to identify if yours is affected
- Compare to your device labeling and lot numbers shown in the recall notice.
- Check if the device is implanted and requires follow-up.
Where to find product info
Labeling on the device packaging and IFU. FDA recall page linked in the notice.
What timeline to expect
Recall notices and guidance are issued by manufacturer; remediation timelines vary. Immediate action is required for MRI safety.
If the manufacturer is unresponsive
- Document attempts to contact I.T.S. GmbH.
- Consult your surgeon for interim imaging and management.
- Escalate to regulatory authorities if there is no response within a reasonable period.
How to prevent similar issues
- Verify MRI compatibility before any imaging after implantation.
- Ask supplier about MRI safety with implants.
- Maintain updated IFU for implanted devices.
Documentation advice
Keep recall notices, labeling, article numbers and lot numbers, and all correspondence with surgeon and manufacturer.
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Product Details
Group 1: DFL Distal Femur Locking Distal Femur Plate — Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. Group 2: PTL Proximal Lateral Tibia Plate — Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. Group 3: PTL Proximal Medial Tibia Plate — Article Numbers: 21325-4, 21325-7. Quantity: 176 units. Sold nationwide in the United States in the states listed in the recall notice. Sold date range not specified. Manufacturer: I.T.S. GmbH. Remedy: Stop using the device immediately. Contact I.T.S. GmbH or healthcare provider for instructions.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MRI safety testing found higher RF-induced heating
- Article numbers span 21301-5 through 21302-13 for distal femur plates and 21321-12 through 21325-7
- No injuries reported
- Immediate stop-use guidance
- US nationwide distribution in multiple states
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Safety Guide
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