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
- Anterolateral Calcaneus Plate
- Model numbers
- Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
- 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 FR.O.H. Calcaneus Repair System is an orthopedic implant used to fix calcaneus (heel bone) fractures. The Anterolateral Calcaneus Plate is part of a stabilization system used by surgeons in complex fracture repairs.
Why This Is Dangerous
MRI scans on patients with the implant may experience higher RF-induced heating under specific MRI conditions. This heating could potentially injure surrounding tissue if not addressed.
Industry Context
This recall is not described as part of a broader industry pattern; it relates specifically to MRI safety testing updates for this device.
Real-World Impact
The risk is limited to MRI procedures involving the implant. The recall requires immediate discontinuation of use and coordination with the manufacturer for safe handling or replacement.
Practical Guidance
How to identify if yours is affected
- Confirm you have FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate Article 21064-60
- Check associated lot numbers 679/012318 or 679/0722100
- Verify the device was distributed in the US
- Locate manufacturer recall notification email
- Consult with your healthcare provider for next steps
Where to find product info
Refer to the recall notice email and the FDA enforcement page for Z-1595-2026
What timeline to expect
Remedy processing timelines are determined by the manufacturer and health regulatory coordination; typically weeks to months
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer
- Escalate to your hospital risk management or patient safety office
- File a report with the FDA if no action is taken in a reasonable period
How to prevent similar issues
- For future implants, verify MRI safety compatibility and check for recall notices before use
- Request updated IFUs and MRI guidelines from surgeons or manufacturers
- Maintain a personal record of all implant device IDs and lot numbers
Documentation advice
Keep all recall notices, emails, and correspondence with healthcare providers and the manufacturer. Photograph labels and packaging if possible.
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Product Details
Product: FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate Article Number: 21064-60 Lot Numbers: 679/012318, 679/0722100 Sold in: United States nationwide (AL, AZ, BVI, 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) Recall Date: 2026-01-23 Quantity Recalled: 4 Manufacturer: I.T.S. GmbH Price: Unknown Sold Through: Healthcare providers and distribution channels in the US (not consumer retail)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot Numbers 679/012318 and 679/0722100
- US nationwide distribution (states listed)
- No injuries reported
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Safety Guide
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