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
- Foot Locking Plates System and Hallux Osteotomy Locking Plate
- Model numbers
- 1. Article Number (Lot Numbers): 37303-10 (18/151720, 18/268729, 679/032432, 679/072268, 679/102237, 679/102307), 37303-12 (18/570637, 679/032434 +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
Foot locking plate systems and hallux osteotomy plates are used to stabilize fractures or correct toe alignment. Surgeons implant these devices during foot surgery.
Why This Is Dangerous
MRI RF heating can cause the implanted device to heat during scans, potentially damaging surrounding tissue.
Industry Context
This recall is not part of a broader industry pattern at this time.
Real-World Impact
Patients may need MRI avoidance or alternate imaging strategies until devices are assessed; healthcare providers may require guidance for imaging planning.
Practical Guidance
How to identify if yours is affected
- Check the device packaging and IFU for the article numbers.
- Match with the list of affected article numbers provided in the recall notice.
- If uncertain, contact the hospital's orthopedic department or I.T.S. GmbH for confirmation.
Where to find product info
Look for the article numbers on the device packaging or IFU; the recall page lists all affected numbers.
What timeline to expect
4-8 weeks for refunds or replacements after initiating contact.
If the manufacturer is unresponsive
- Escalate to hospital risk management or patient safety office.
- File a report with the FDA recall portal if needed.
- Consult legal counsel if there is harm and the company is unresponsive.
How to prevent similar issues
- When buying future orthopedic implants, verify MRI compatibility and review the IFU.
- Consult your surgeon about MRI risk for implanted devices.
- Keep a record of all device identifiers and supplier communications.
Documentation advice
Document all communications, keep serial numbers, and save emails or letters from the manufacturer.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Article numbers span multiple product descriptions
- MRI RF heating risk under specific MRI conditions
- US nationwide distribution
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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