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Moderate riskFDA DeviceClass II

I.T.S. GmbH humeral head plate recalled for MRI safety labeling issue

I.T.S. GmbH issued a recall for certain Humeral Head Plate with Angular Stability implants used in shoulder surgery. Testing found the device may heat up more than expected during MRI scans under certain conditions. The product labeling did not reflect these updated safety findings.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have received this implant, contact your surgeon with your implant article and lot number
  2. Tell any healthcare provider about this implant before undergoing an MRI scan
  3. Ask your doctor whether MRI is safe for you or if alternative imaging is needed
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 17 products — see all of them.

Details

Units affected
292 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1594-2026

In the FDA's words

Description
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4. Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366, 26/F65626, 26/F656261, 26/F66145, 26/F661451, 26/F66496, 26/F66905, 26/F669051, 26/F73497, 679/012439, 679/022450), 211341-7 (26/F63367, 26/F65627, 26/F66146, 26/F66906, 679/012440), 21134-4 (768/18758, 768/19642), 21134-5 (778/201904), 21135-4 (26/F67801, 768/21382), 21136-4 (26/F65629, 26/F66907, 26/F67802, 26/F70071, 768/21383), 21136-5 (770/101901), 21136-7 (26/F65039, 26/F65630), 21137-4 (26/F65631, 26/F67804, 768/21384), 21137-7 (26/F65040), 21138-4 (26/F65633, 26/F66908, 26/F67806), 21139-4 (26/F65634, 26/F67807, 768/21386). Distribution: 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 quantity: 292 units
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

17 products in this recall

I.T.S. bone plates and screws recalled for MRI heating risk

I.T.S. is recalling 17 orthopedic implant product lines, including bone plates and screw systems. Updated MRI safety testing found that these implants can heat up more during certain MRI conditions than the product instructions previously stated. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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