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
- Hand Locking Plates System
- Model numbers
- 1. Article Number (Lot Numbers): 32151-6 (18/408462, 18/500495, 18/691266), 32151-8 (18/408866, 18/531370), 32151-9 (18/351668, 18/541373, 18/741269) +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 HLS Hand Locking Plates System is a modular orthopedic hardware set used to fix and stabilize bones in the hand and digits during reconstructive or fracture procedures.
Why This Is Dangerous
MRI exposure can cause the device to heat more than previously indicated, potentially leading to burns or tissue injury in patients undergoing scanning.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and patients may need to identify affected implants in inventory. MRI scheduling for affected devices could require adjustment to minimize patient risk and treatment delays.
Practical Guidance
How to identify if yours is affected
- Review device labeling for article numbers listed in the recall.
- Compare your device’s article numbers to the recalled list.
- Consult your surgeon if you are unsure whether your device is affected.
Where to find product info
Article numbers printed on device packaging and IFU. Manufacturer notices and the FDA page also list ranges.
What timeline to expect
Remediation timelines are not published; expect weeks to months for refunds or replacements after verification.
If the manufacturer is unresponsive
- Escalate to hospital risk management or patient safety office.
- File a formal recall complaint with ITS GmbH and the FDA if needed.
How to prevent similar issues
- Verify MRI compatibility before scheduling scans for patients with implanted hardware.
- Follow manufacturerCompatibility guidelines and update medical records with device identifiers.
- Request replacement plans or alternative imaging protocols if necessary.
Documentation advice
Keep all recall notices, EMR entries, device labels, and communications with ITS GmbH. Document dates and actions taken.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution nationwide across the United States
- MRI RF heating risk confirmed by updated testing
- IFU did not reflect higher temperature increases under some MRI conditions
- Article numbers span Cortical Screws, HLS Plates, and Locking Stabilization Screws
- Notification by email
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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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