The Recall Desk
HighFDA (Devices)·Z-1596-2026·Announced 2026-04-01

I.T.S. pilon and tibia plates heat more in MRI than stated

I.T.S. GmbH is recalling Pilon Plates with Angular Stability and Anterolateral Tibia Plates because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: implanted hardware may heat more during MRI than its instructions state, and no injuries are stated in the source.

Plain-English summary

I.T.S. GmbH is recalling the Pilonplate with Angular Stability, covering anterolateral tibia plates, 4 mm pilon plates and small pilon plates across twelve article numbers. About 101 units were distributed across 30 US states and territories. The FDA has classified this recall as Class II.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.

Affected product is listed by article number and lot number in the FDA enforcement record.

Facilities can identify affected implants by the article and lot numbers, and may contact I.T.S. GmbH for further information.

The recalled product

Product
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 2109
Manufacturer
I.T.S. GmbH
Category
Medical Device — Orthopaedic implant
Hazard
  • mri-heating
  • rf-induced-heating
  • instructions-understated

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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)
  • 21312-7 (26/F65643
  • 26/F67827). 2. Article Number (Lot Numbers): 21094-10 (643/032304
  • 643/082309)
  • 21094-4 (643/0572
  • 643/0571)
  • 21094-6 (643/112202)
  • 21094-8 (643/012309). 3.Article Number (Lot Numbers): 21093-4 (679/032311
  • 679/112331)
  • 21093-6 (679/112332).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category