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
31207-1031207-1231207-1431207-1631207-1831207-2031207-2431207-2631207-2831207-3031257-1231257-1431257-1631257-1831257-2031257-2231257-2431257-2831257-3031307-1831307-3231307-3431307-3631307-3831358-3031437-3031437-3831437-4031437-5031757-10031757-12031757-4531757-8031757-8531757-90
- Lot codes and dates
- Article Number (Lot Numbers)
31207-10 (679/112002)31207-12 (679/092133679/102343679/112006)31207-14 (679/102050)31207-16 (679/102345679/102049)31207-18 (679/0323110679/102355679/112001)31207-20 (679/0323111679/102051679/102356)31207-24 (679/102028)31207-26 (679/112008)31207-28 (679/112009)31207-30 (679/032314086/483377)31257-12 (679/081904)31257-14 (679/042323679/081905)31257-16 (679/042324)31257-18 (679/112308679/022128)31257-20 (679/022123679/042326679/112321)31257-22 (679/022124679/042327679/112325)31257-24 (679/022125679/112326)31257-28 (679/022130679/052306)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 (679/032406679/071903)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)
- Article Number (Lot Numbers)
- 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.
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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