HIGH

ITS GmbH Pilon Plate with Angular Stability Recalled for MRI Heating Risk (2026) 101 Units

ITS GmbH recalls 101 Pilon Plate with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

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

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

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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. 1) Review your medical records for the listed article numbers.
  2. 2) Compare implant labels or IFU for the exact model numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7, 21094-10, 21094-4, 21094-6, 21094-8, 21093-4, 21093-6.
  3. 3) If matched, contact ITS GmbH and your surgeon for instructions.
  4. 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.

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

  • 101 units recalled
  • 3 article-number groups affected
  • A1 Anterolateral Tibia Plate: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7
  • A2 Pilon Plate 4mm: 21094-10, 21094-4, 21094-6, 21094-8
  • A3 Pilon Plate Small: 21093-4, 21093-6
  • Distribution: Nationwide across 30+ states and territories
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Classification

Product TypePilon Plate with Angular Stability
Sold At
Multiple Retailers

Product Details

Model Numbers
1. Article Number (Lot Numbers): 21311-11 (26/F62573)
21311-15 (26/F65048
26/F67521)
21311-7 (26/F66165
26/F67825)
+12 more
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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