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

    • 31404-16
    • 31404-18
    • 31404-20
    • 31404-22
    • 31404-24
    • 31404-26
    • 31404-28
    • 31404-30
    • 31404-32
    • 31404-34
    • 31404-36
    • 31404-38
    • 31404-40
    • 31404-42
    • 31404-44
    • 31404-46
    • 31404-48
    • 31404-50
    • 31404-55
    • 31404-60
    • 31404-65
    • 31404-70
    • 31404-75
    • 31404-80
    • 31457-30
    • 31457-36
    • 31457-40
    • 31457-46
    • 31457-50
    • 31457-55
    • 31457-60
    • 31652-100
    • 31652-105
    • 31652-110
    • 31652-115
    • 31652-120
    • 31652-25
    • 31652-30
    • 31652-35
    • 31652-40
    • 31652-45
    • 31652-55
    • 31652-60
    • 31652-65
    • 31652-70
    • 31652-75
    • 31652-80
    • 31652-85
    • 31652-90
    • 31652-95
    • 31731-100
    • 31731-105
    • 31731-110
    • 31731-115
    • 31731-120
    • 31731-50
    • 31731-60
    • 31731-65
    • 31731-70
    • 31731-75
  • Article Numbers
    • 31357-44
    • 31357-22
    • 31357-48
    • 31277-18
    • 31357-20
    • 31357-22
    • 31357-24
    • 31357-26
    • 31357-28
    • 31357-30
    • 31357-32
    • 31357-34
    • 31357-36
    • 31357-38
    • 31357-40
    • 31357-42
    • 31357-44
    • 31357-46
    • 31357-48
    • 31357-60
    • 31357-65
    • 31357-70. 3. Washer
  • Article Number36851. 4. Washer, Concave
  • Article Numbers
    • 36432
    • 36653
    • 36732. 5. Washer
    • Flat
  • Article Numbers
    • 36431
    • 36651
    • 36653
    • 36731
Lot codes and dates
  • 1
  • Article Number (Lot Numbers)

    245 of 245 codes

    • 31404-16 (679/062339
    • 679/122213
    • 679/122332)
    • 31404-18 (679/122212
    • 679/062340)
    • 31404-20 (18/089221
    • 679/062343
    • 679/122241)
    • 31404-22 (18/061535
    • 679/012416
    • 679/062350)
    • 31404-24 (18/071536
    • 679/062362
    • 679/122246)
    • 31404-26 (679/122245
    • 679/062363)
    • 31404-28 (18/186278
    • 679/062364)
    • 31404-30 (18/187299
    • 679/012401
    • 679/062365
    • 679/122242)
    • 31404-32 (18/111540
    • 679/062366
    • 679/122211)
    • 31404-34 (679/122206
    • 18/121544
    • 679/012402
    • 679/042414
    • 679/072302
    • 679/122206)
    • 31404-36 (18/188300
    • 679/052403
    • 679/072305
    • 679/112223)
    • 31404-38 (18/189301
    • 679/112213
    • 679/012455
    • 679/072309)
    • 31404-40 (18/181043
    • 679/062321
    • 679/122201
    • 679/122310
    • 679/052404
    • 679/032532)
    • 31404-42 (679/122203
    • 18/191303
    • 679/072310
    • 679/012418
    • 679/052424
    • 679/052505)
    • 31404-44 (18/192304
    • 679/112232
    • 679/052332
    • 679/052425
    • 679/052508)
    • 31404-46 (679/122240
    • 679/062322
    • 679/112210
    • 679/052426
  • 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 (18/165201
    • 18/341054)
    • 31357-32 (18/166217)
    • 31357-34 (18/167218)
    • 31357-36 (18/168219
    • 26/F65910)
    • 31357-38 (18/167220)
    • 31357-40 (26/F65911
    • 18/170221)
    • 31357-42 (26/F65912)
    • 31357-44 (18/171222
    • 18/361059
    • 26/F65913)
    • 31357-46 (18/861060)
    • 31357-48 (18/172223
    • 26/F65914)
    • 31357-60 (26/F65648)
    • 31357-65 (679/012125)
    • 31357-70 (18/902013). 3
  • Article Number (Lot Numbers)
    • 36851 (26/F59918
    • 26/F61351
    • 26/F64885
    • 26/F64886
    • 26/F65908
    • 26/F66506
    • 26/F71413
    • 26/F71764
    • 26/F72364
    • 26/F73020
    • 26/F74288). 4
  • Article Number (Lot Numbers)
    • 36432 (26/F65379
    • 26/F67799
    • 26/F72744
    • 774/300002)
    • 36653 (26/F62590
    • 26/F68455)
    • 36732 (26/F67800). 5
  • Article Number (Lot Numbers)
    • 36431 (26/F62589
    • 26/F65378
    • 26/F66505
    • 26/F67798
    • 26/F70092
    • 26/F72743
    • 26/F73017
    • 26/F73494)
    • 36651 (26/F61694
    • 26/F65380
    • 26/F68454
    • 26/F73018)
    • 36653 (26/F73019)
    • 36731 (26/F60987
    • 26/F62591
    • 26/F67523
    • 26/F70093
    • 26/F72363
    • 26/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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 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.