Reported Apr 1, 2026 · Ongoing
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 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, 21234-4, 21235-4. |
| 2 | I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. |
| 3 | UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20. |
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
21232-3 (26/F65636)21232-4 (26/F6172226/F65637)21232-6 (26/F6256426/F65638)21233-3 (26/F65639)21233-4 (26/F65640)21233-6 (26/F6172326/F65046)21234-4 (26/F6564126/F66504)21235-4 (26/F6564226/F67810). 2
- Article Number (Lot Numbers)
21231-6 (643/012301643/022310643/032308643/0630643/0657643/102402643/122301). 3
- Article Number (Lot Numbers)
37302-18 (18/636447)37302-20 (18/802189)
- Amount recalled
- 120 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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