Reported Apr 1, 2026 · Ongoing
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated;…
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. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated
- Article Numbers
81 of 81 codes
31404-1631404-1831404-2031404-2231404-2431404-2631404-2831404-3031404-3231404-3431404-3631404-3831404-4031404-4231404-4431404-4631404-4831404-5031404-5531404-6031404-6531404-7031404-7531404-8031457-3031457-3631457-4031457-4631457-5031457-5531457-6031652-10031652-10531652-11031652-11531652-12031652-2531652-3031652-3531652-4031652-4531652-5531652-6031652-6531652-7031652-7531652-8031652-8531652-9031652-9531731-10031731-10531731-11031731-11531731-12031731-5031731-6031731-6531731-7031731-75
- Article Numbers
31357-4431357-2231357-4831277-1831357-2031357-2231357-2431357-2631357-2831357-3031357-3231357-3431357-3631357-3831357-4031357-4231357-4431357-4631357-4831357-6031357-6531357-70. 3. Washer
- Article Number36851. 4. Washer, Concave
- Article Numbers
364323665336732. 5. WasherFlat
- Article Numbers
36431366513665336731
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
245 of 245 codes
31404-16 (679/062339679/122213679/122332)31404-18 (679/122212679/062340)31404-20 (18/089221679/062343679/122241)31404-22 (18/061535679/012416679/062350)31404-24 (18/071536679/062362679/122246)31404-26 (679/122245679/062363)31404-28 (18/186278679/062364)31404-30 (18/187299679/012401679/062365679/122242)31404-32 (18/111540679/062366679/122211)31404-34 (679/12220618/121544679/012402679/042414679/072302679/122206)31404-36 (18/188300679/052403679/072305679/112223)31404-38 (18/189301679/112213679/012455679/072309)31404-40 (18/181043679/062321679/122201679/122310679/052404679/032532)31404-42 (679/12220318/191303679/072310679/012418679/052424679/052505)31404-44 (18/192304679/112232679/052332679/052425679/052508)31404-46 (679/122240679/062322679/112210679/052426
- Article Number (Lot Numbers)
31277-18 (26/F36049)31357-20 (18/091247)31357-22 (679/031707)31357-24 (86/485378)31357-26 (18/121250)31357-28 (26/F65909)31357-30 (18/16520118/341054)31357-32 (18/166217)31357-34 (18/167218)31357-36 (18/16821926/F65910)31357-38 (18/167220)31357-40 (26/F6591118/170221)31357-42 (26/F65912)31357-44 (18/17122218/36105926/F65913)31357-46 (18/861060)31357-48 (18/17222326/F65914)31357-60 (26/F65648)31357-65 (679/012125)31357-70 (18/902013). 3
- Article Number (Lot Numbers)
36851 (26/F5991826/F6135126/F6488526/F6488626/F6590826/F6650626/F7141326/F7176426/F7236426/F7302026/F74288). 4
- Article Number (Lot Numbers)
36432 (26/F6537926/F6779926/F72744774/300002)36653 (26/F6259026/F68455)36732 (26/F67800). 5
- Article Number (Lot Numbers)
36431 (26/F6258926/F6537826/F6650526/F6779826/F7009226/F7274326/F7301726/F73494)36651 (26/F6169426/F6538026/F6845426/F73018)36653 (26/F73019)36731 (26/F6098726/F6259126/F6752326/F7009326/F7236326/F73495)
- Amount recalled
- 5,568 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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