Reported Apr 1, 2026 · Ongoing

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers:…

I.T.S. GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: I.T.S. GmbH · Autal 28 · Lasnitzhohe · N/A

Is this the product you have?

  • Volar Radius Plate with Angular Stability
  • with the following descriptionRadius 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
Lot codes and dates
  • Article Number (Lot Numbers)

    62 of 62 codes

    • 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
    • 643/102201
    • 679/0323121
    • 679/0323120
    • 679/0323120
    • 679/0323120
    • 679/0323120
    • 679/0323120
    • 679/0323120
    • 679/0323120
    • 679/0323120
    • 643/102201
    • 643/102201
    • 643/102201
    • 643/102201
    • 679/0323120
    • 679/0323120)
    • 21032-11 (679/112312)
    • 21032-3 (679/032241
    • 643/0623
    • 679/042293
    • 679/0323122
    • 679/062367
    • 679/052318
    • 643/022501
    • 643/062501
    • 643/072501
    • 643/102502)
    • 21032-5 (679/122136
    • 679/0323143
    • 679/042337)
    • 21033-3 (679/062212
    • 679/022301
    • 679/042338
    • 679/022302)
    • 21033-5 (643/0629
    • 26/F24901
    • 679/012311)
    • 21034-3 (679/062221
    • 679/012312
    • 679/072217
    • 679/042339)
    • 21034-5 (643/102202
    • 679/012314
    • 679/012313)
    • 21035-3 (679/062222
    • 679/042308
    • 643/012501
    • 643/0548)
    • 21036-3 (679/062213
Amount recalled
220 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.