The Recall Desk
HighFDA (Devices)·Z-1595-2026·Announced 2026-04-01

I.T.S. calcaneus repair plate heats more in MRI than stated

I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System anterolateral calcaneus plate 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 FR.O.H. Calcaneus Repair System anterolateral calcaneus plate, article number 21064-60. About 4 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 covers lots 679/012318 and 679/0722100.

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

The recalled product

Product
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
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 (2)

  • Article Number (Lot Numbers): 21064-60 (679/012318
  • 679/0722100).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category