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
- Pilon Plate with Angular Stability
- Model numbers
- 1. Article Number (Lot Numbers): 21311-11 (26/F62573), 21311-15 (26/F65048, 26/F67521), 21311-7 (26/F66165, 26/F67825), 21312-11 (26/F65049, 26/F67826), 21312-15 (26/F66166) +9 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
Pilon Plate with Angular Stability is an orthopedic implant used to stabilize pilon fractures of the tibia. The implants come in several sizes and are distributed nationwide for surgical use.
Why This Is Dangerous
The defect relates to MRI safety. RF energy during MRI can cause higher temperature increases at the implant site, potentially posing a burn risk to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Patients with the affected implants should avoid MRI with the implants until cleared. The recall affects 101 units but does not report injuries to date. Healthcare providers will determine next steps for each patient.
Practical Guidance
How to identify if yours is affected
- 1) Review your medical records for the listed article numbers.
- 3) If matched, contact ITS GmbH and your surgeon for instructions.
- 4) Do not undergo MRI until advised.
Where to find product info
Recall notices are available via ITS GmbH communications and the FDA enforcement page for Z-1596-2026.
What timeline to expect
No specific timeline for remediation is stated in the recall notice.
If the manufacturer is unresponsive
- Escalate to your hospital patient safety officer or risk management.
- File a report with the appropriate medical device regulator if you believe you are affected and not receiving guidance.
How to prevent similar issues
- Verify MRI compatibility information before undergoing imaging for any implanted devices.
- Ask surgeons to review MRI safety data before future imaging.
- Monitor recall communications for updates on refunds, replacements, or device removals.
Documentation advice
Keep copies of the recall notice, model numbers, surgeon correspondence, and any MRI scheduling notes. Document all communications with the manufacturer and healthcare providers.
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Product Details
- Anterolateral Tibia Plate: Article Numbers 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7 - Pilon Plate 4mm: Article Numbers 21094-10, 21094-4, 21094-6, 21094-8 - Pilon Plate, Small: Article Numbers 21093-4, 21093-6 - Units recalled: 101 - Distribution: US Nationwide - Regions: 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, WY
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3 article-number groups affected
- A3 Pilon Plate Small: 21093-4, 21093-6
- Distribution: Nationwide across 30+ states and territories
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Safety Guide
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