Reported Apr 1, 2026 · Ongoing

Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook…

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?

  • Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate
  • Article Numbers
    • 21112-7
    • 21114-5
    • 21113-9. 2. Olecranon Plate
  • Article Numbers
    • 21111-6
    • 21111-8
    • 21111-12
Lot codes and dates
  • 1
  • Article number (Lot Numbers)
    • 21112-7 (643/0549)
    • 21114-5 (643/032301
    • 643/042303
    • 643/042304
    • 643/0618
    • 643/102211
    • 643/112304)
    • 21113-9 (643/072320). 2
  • Article number (Lot Numbers)
    • 21111-6 (643/032306
    • 643/072319
    • 643/112201)
    • 21111-8 (643/032318)
    • 21111-12 (643/032305)
Amount recalled
70 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, 5:38 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.