The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1592-2026·Announced 2026-04-01

I.T.S. volar radius plates heat more in MRI than stated

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 Volar Radius Plate with Angular Stability, the Radius Plate PROlock II, across eleven article numbers. About 220 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
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
Manufacturer
I.T.S. GmbH
Category
Medical Device — Orthopaedic implant
Hazard
Affected units
220

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 (20)

  • Article Number (Lot Numbers): 21031-3 (679/042207
  • 679/032240
  • 679/0323115
  • 679/052317
  • 26/F70606
  • 679/032253
  • 643/032501
  • 643/072503
  • 643/102501)
  • 21031-5 (43/0015
  • 643/102201
  • 679/0323121
  • 679/0323120
  • 679/0323120)
  • 21032-11 (679/112312)
  • 21032-3 (679/032241
  • 643/0623
  • 679/042293
  • 679/0323122
  • 679/062367

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 17 recalled by I.T.S. GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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