The Recall Desk
HighFDA (Devices)·Z-1604-2026·Announced 2026-04-01

I.T.S. distal ulna plates heat more in MRI than instructions state

I.T.S. GmbH is recalling the Distal Ulna Locking and Ulna Osteotomy Locking Systems 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 I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System, covering distal ulna plates, ulna osteotomy plates and locking cancellous screws. About 120 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
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21
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 (20)

  • 1. Article Number (Lot Numbers): 21232-3 (26/F65636)
  • 21232-4 (26/F61722
  • 26/F65637)
  • 21232-6 (26/F62564
  • 26/F65638)
  • 21233-3 (26/F65639)
  • 21233-4 (26/F65640)
  • 21233-6 (26/F61723
  • 26/F65046)
  • 21234-4 (26/F65641
  • 26/F66504)
  • 21235-4 (26/F65642
  • 26/F67810). 2. Article Number (Lot Numbers): 21231-6 (643/012301
  • 643/022310
  • 643/032308
  • 643/0630
  • 643/0657
  • 643/102402
  • 643/122301). 3. Article Number (Lot Numbers): 37302-18 (18/636447)
  • 37302-20 (18/802189).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category