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
- Volar Radius Plate PROlock II
- Model numbers
- Article Number (Lot Numbers): 21031-3 (679/042207, 679/032240, 679/0323115, 679/052317, 26/F70606, 679/032253, 643/032501, 643/072503 +5 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 Volar Radius Plate PROlock II is used to fix distal radius fractures. It provides angular stability for fracture fixation in surgical procedures.
Why This Is Dangerous
MRI exposure may cause higher RF-induced heating in the presence of the device under certain scanner conditions. That heating could pose a risk to surrounding tissue.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Clinicians and patients may need to modify MRI plans or remove/replace the device to ensure patient safety. No injuries have been reported to date, but the risk warrants precaution.
Practical Guidance
How to identify if yours is affected
- Compare with listed lot numbers if available
- Consult your healthcare provider or ITS for confirmation
Where to find product info
Labeling on the implant packaging and the Instructions for Use; manufacturer recall notice; ITS website or patient communications
What timeline to expect
Recall resolution or replacement instructions typically take 4-6 weeks, subject to manufacturer logistics
If the manufacturer is unresponsive
- Escalate to healthcare providers for interim guidance
- Contact the FDA recall program if you cannot reach the manufacturer
- Keep all records of communication
How to prevent similar issues
- Verify MRI compatibility for implants before imaging
- Ask for MRI safety documentation when selecting implants
- Maintain an updated registry of implanted devices for patients and clinicians
Documentation advice
Retain recall notices, take photos of device labeling, document dates of communication with providers and manufacturers
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Product Details
Product: Volar Radius Plate with Angular Stability, PROlock II Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3 and related lot numbers Quantity: 220 units Distribution: US Nationwide (AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W) Sold At: Multiple Retailers Recall Date: 2026-01-23 Status: Active Hazard: Higher RF-induced temperature increases during MRI under certain conditions beyond what is described in the IFU Remedy: Stop using the device and follow
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 220 units
- Distribution: US nationwide in many states
- Hazard: MRI heating risk during scans
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Safety Guide
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