Reported Apr 1, 2026 · Ongoing

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12,…

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?

  • HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated
  • Article Numbers
    • 31207-10
    • 31207-12
    • 31207-14
    • 31207-16
    • 31207-18
    • 31207-20
    • 31207-24
    • 31207-26
    • 31207-28
    • 31207-30
    • 31257-12
    • 31257-14
    • 31257-16
    • 31257-18
    • 31257-20
    • 31257-22
    • 31257-24
    • 31257-28
    • 31257-30
    • 31307-18
    • 31307-32
    • 31307-34
    • 31307-36
    • 31307-38
    • 31358-30
    • 31437-30
    • 31437-38
    • 31437-40
    • 31437-50
    • 31757-100
    • 31757-120
    • 31757-45
    • 31757-80
    • 31757-85
    • 31757-90
Lot codes and dates
  • Article Number (Lot Numbers)
    • 31207-10 (679/112002)
    • 31207-12 (679/092133
    • 679/102343
    • 679/112006)
    • 31207-14 (679/102050)
    • 31207-16 (679/102345
    • 679/102049)
    • 31207-18 (679/0323110
    • 679/102355
    • 679/112001)
    • 31207-20 (679/0323111
    • 679/102051
    • 679/102356)
    • 31207-24 (679/102028)
    • 31207-26 (679/112008)
    • 31207-28 (679/112009)
    • 31207-30 (679/0323140
    • 86/483377)
    • 31257-12 (679/081904)
    • 31257-14 (679/042323
    • 679/081905)
    • 31257-16 (679/042324)
    • 31257-18 (679/112308
    • 679/022128)
    • 31257-20 (679/022123
    • 679/042326
    • 679/112321)
    • 31257-22 (679/022124
    • 679/042327
    • 679/112325)
    • 31257-24 (679/022125
    • 679/112326)
    • 31257-28 (679/022130
    • 679/052306)
    • 31257-30 (679/022131)
    • 31307-18 (679/061907)
    • 31307-32 (679/062285)
    • 31307-34 (679/062286)
    • 31307-36 (679/062287)
    • 31307-38 (679/032118)
    • 31358-30 (26/F67790)
    • 31437-30 (679/071916)
    • 31437-38 (679/071918)
    • 31437-40 (679/032406
    • 679/071903)
    • 31437-50 (679/071920)
    • 31757-100 (35/51892)
    • 31757-120 (86/320792)
    • 31757-45 (86/320793)
    • 31757-80 (26/F55872)
    • 31757-85 (26/F55873)
    • 31757-90 (26/F55874)
Amount recalled
623 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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 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.