Reported Apr 1, 2026 · Ongoing
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL…
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. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate
- Article Numbers21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate
- Article Numbers21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate
- Article Numbers
21325-421325-7
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
21301-5 (26/F62569)21301-7 (26/F62570)21301-9 (26/F67518)21301-13 (26/F6256826/F67815)21302-5 (26/F67520)21302-7 (26/F67821)21302-9 (26/F6257226/F67822)21302-13 (26/F6257126/F6751926/F67820). 2
- Article Number (Lot Numbers)
21321-7 (26/F5495526/F62576)21321-12 (26/F55883)21322-7 (26/F5589026/F62578)21322-12 (26/F62577). 3
- Article Number (Lot Numbers)
21325-4 (26/F70528679/022433679/032217679/102240679/102242679/102303)21325-7 (679/102241679/102304)
- Amount recalled
- 176 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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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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