Reported Apr 1, 2026 · Ongoing
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.…
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?
- I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate
- Article Numbers
21602-321602-421602-521602-621602-721602-821603-321603-421603-521603-621603-721603-8. 2. Fibula Plate 3.5mm
- Article Numbers
21225-421225-621225-821225-1021225-1221226-421226-621226-821226-1021226-12. 3. Universal Tubular Plate
- Article Numbers
21601-521601-621601-721601-821601-1021601-1221601-1421601-16
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
21602-3 (643/072330643/092310)21602-4 (643/072301643/072308)21602-5 (643/022417643/0650643/072309)21602-6 (643/042305643/072333)21602-7 (643/072332643/082305)21602-8 (43/0405643/012305)21603-3 (643/072331643/082306)21603-4 (643/102214643/102206643/072302643/022313643/032310)21603-5 (643/072335643/122308)21603-6 (643/022309643/072305643/072311643/122309)21603-7 (643/072337643/082313)21603-8 (643/072312643/122204). 2
- Article Number (Lot Numbers)
21225-4 (768/2089426/F6504126/F66149679/092305679/02243026/F70514126/F7236226/F73634)21225-6 (768/20895768/2003926/F6504226/F6615026/F66499679/09232126/F705161679/06245926/F7051626/F73635)21225-8 (768/2089626/F6563526/F6650026/F70515)21225-10 (26/F66497)21225-12 (26/F66498679/012438)21226-4 (26/F6504326/F6615226/F6650126/F7052126/F705211679/012412679/062306679/092306768/20897768/208978)21226-6 (26/F3543326/F6504426/F6650226/F7052226/F705221679/062307679/092307768/20898)21226-8 (26/F66503679/012413768/20045768/20899)21226-10 (26/F66151)21226-12 (26/F66148679/012411). 3
- Article Number (Lot Numbers)
21601-5 (643/012302643/072323)21601-6 (643/072326770/201904)21601-7 (643/012303643/022308643/0647643/072315643/072327643/082303)21601-8 (643/072328643/072329)21601-10 (643/022312643/082301643/082302)21601-12 (26/F70342)21601-14 (26/F70343)21601-16 (26/F70344)
- Amount recalled
- 869 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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