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Moderate riskFDA DeviceClass II

I.T.S. GmbH clavicle plates recalled for higher MRI heating risk

I.T.S. GmbH clavicle plates used in shoulder surgery may heat up more than expected during MRI scans under certain conditions. New testing found higher temperature increases than the original instructions stated. This affects specific article numbers and lot numbers distributed across the US.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have one of these clavicle plates, contact your surgeon or hospital before having an MRI scan.
  2. Ask your doctor about the specific article and lot number of your implant.
  3. Discuss MRI safety precautions with your medical team before any imaging procedure.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 17 products — see all of them.

Details

Units affected
322 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1593-2026

In the FDA's words

Description
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6. 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): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Article Number (Lot Numbers): 21123-4 (00/0810-06, 679/052014, 679/062216), 21124-4 (679/042333, 679/062217, 679/072346), 21127-6 (679/052228), 21128-6 (679/042341). 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: 322 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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