The Recall Desk
HighFDA (Devices)·Z-1602-2026·Announced 2026-04-01

I.T.S. distal humeral plates heat more in MRI than stated

I.T.S. GmbH is recalling Distal Humeral Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously 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 Distal Humeral Plates with Angular Stability, covering locking cortical screws across 28 article numbers and distal humeral plates across five article numbers. About 12,059 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
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 373
Manufacturer
I.T.S. GmbH
Category
Medical Device — Orthopaedic implant
Hazard
Affected units
12,059

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)

  • 1. Article Number (Lot Numbers): 37351-10-N (18/240314
  • 679/122205)
  • 37351-12-N (18/200330
  • 18/943977
  • 26/F65544
  • 679/032401
  • 679/052417
  • 679/122261)
  • 37351-14-N (18/201331
  • 18/511504
  • 18/944978
  • 26/F65545
  • 679/032402
  • 679/032514
  • 679/052244
  • 679/052418
  • 679/052516
  • 679/072520)
  • 37351-16-N (18/202332
  • 18/521505

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 →

Related recalls

Same manufacturer · I.T.S. GmbH

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Same hazard · mri heating

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