FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH HLS Hand Locking Plates System recalled for higher MRI temperature risk
What this means
I.T.S. GmbH has recalled certain cortical screws, locking stabilization screws, and HLS plates used in hand surgery. New MRI safety testing found these implants may heat up more than expected during MRI scans under certain conditions. The original instructions did not reflect this updated safety information.
- If you received one of these implants, contact your surgeon to confirm your specific article and lot numbers.
- Inform your healthcare providers about this recall before any future MRI procedures.
- Ask your surgeon whether your implant requires special precautions or alternative imaging methods.
- Do not have an MRI without first discussing this recall with your surgical team.
The agency's original wording
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Intended for
Adults
Illnesses reported
None reported
Sold states
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, OK, PA, SC, TX, USVI, WV, W.
Affected count
1,307 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1607-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.