Recall Weekly
Moderate riskFDA DeviceClass II

I.T.S. GmbH FR.O.H. Calcaneus Repair System recalled for higher MRI heating risk

I.T.S. GmbH's FR.O.H. Calcaneus Repair System (anterolateral calcaneus plate, Article Number 21064-60) may heat more than expected during MRI scans under certain conditions. New testing found higher radiofrequency-induced temperature increases than the original instructions stated. Only 4 units were distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact the surgeon or facility where your calcaneus plate was implanted
  2. Ask about MRI safety precautions or alternative imaging options before any MRI procedure
  3. Request updated device instructions from your healthcare provider if you have this plate
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 17 products — see all of them.

Details

Units affected
4 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1595-2026

In the FDA's words

Description
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. 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): 21064-60 (679/012318, 679/0722100). 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: 4 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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