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Moderate riskFDA DeviceClass II

I.T.S. GmbH Pilonplate with Angular Stability recalled for MRI safety concern

I.T.S. GmbH has recalled certain Pilonplate devices used in orthopedic surgery because new MRI safety testing found they heat up more than expected during MRI scans under certain conditions. The devices affected include Anterolateral Tibia Plates, Pilon Plates 4mm, and Pilon Plates Small with specific article and lot numbers.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have had surgery with one of these plates, contact your surgeon or orthopedic doctor with your implant information
  2. Do not have an MRI scan until you speak with your doctor about your implant
  3. Ask your doctor about your implant's specific article and lot number to determine if it is affected
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 17 products — see all of them.

Details

Units affected
101 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1596-2026

In the FDA's words

Description
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6. Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). 1. Article Number (Lot Numbers): 21311-11 (26/F62573), 21311-15 (26/F65048, 26/F67521), 21311-7 (26/F66165, 26/F67825), 21312-11 (26/F65049, 26/F67826), 21312-15 (26/F66166), 21312-7 (26/F65643, 26/F67827). 2. Article Number (Lot Numbers): 21094-10 (643/032304, 643/082309), 21094-4 (643/0572, 643/0571), 21094-6 (643/112202), 21094-8 (643/012309). 3.Article Number (Lot Numbers): 21093-4 (679/032311, 679/112331), 21093-6 (679/112332). 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: 101 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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