Recall Weekly
Moderate riskFDA DeviceClass II

I.T.S. GmbH olecranon plates recalled for MRI heating risk

I.T.S. GmbH olecranon plates and olecranon hook plates used in orthopedic surgery may heat up more than expected during MRI scans under certain conditions. Updated safety testing found higher temperature increases than the original instructions stated.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received an olecranon plate or hook plate from I.T.S. GmbH, contact your surgeon or hospital immediately with your article and lot numbers.
  2. Before any MRI scan, inform the MRI technician that you have this implant and share the updated safety information from I.T.S. GmbH.
  3. Do not proceed with MRI until you confirm with your medical team that it is safe given the new testing data.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 17 products — see all of them.

Details

Units affected
70 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1597-2026

In the FDA's words

Description
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12. 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): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), 21113-9 (643/072320). 2. Article number (Lot Numbers): 21111-6 (643/032306, 643/072319, 643/112201), 21111-8 (643/032318), 21111-12 (643/032305). 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: 70 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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