I.T.S. GmbH 2026-04-01 Health serious FDA
Health · FDA · Recall #FDA-Z-1606-2026
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article… Recall
Issued April 1, 2026 · I.T.S. GmbH
In April 2026, I.T.S. GmbH recalled the HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
What you should do
- 1 Stop using HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact I.T.S. GmbH to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- I.T.S. GmbH
- Category
- Health
- Recall date
- April 1, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH,
- Recall number
- FDA-Z-1606-2026
- Made in
- Austria
- Issuing agency
- FDA
In context
- I.T.S. GmbH has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.