Recall Weekly
Moderate riskFDA DeviceClass II

I.T.S. GmbH distal humeral plates recalled for higher MRI heating than labeled

I.T.S. GmbH distal humeral plates and locking cortical screws used in arm surgery may heat more than expected during MRI scans under certain conditions. New testing found the heating levels are higher than what the original instructions stated.

From the FDA notice · Read the official notice ↗

What to do

  1. If you had arm surgery with an I.T.S. distal humeral plate or cortical screw, contact your surgeon before having an MRI scan
  2. Provide your surgeon with your implant article number and lot number (found on your implant card or surgical records)
  3. Ask your surgeon about updated MRI safety guidelines for your specific implant
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 17 products — see all of them.

Details

Units affected
12,059 units
Illnesses reported
None reported
Manufactured in
Autal 28, Lasnitzhohe, Austria
Classification
Class II
Recall number
Z-1602-2026

In the FDA's words

Description
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9. 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): 37351-10-N (18/240314, 679/122205), 37351-12-N (18/200330, 18/943977, 26/F65544, 679/032401, 679/052417, 679/122261), 37351-14-N (18/201331, 18/511504, 18/944978, 26/F65545, 679/032402, 679/032514, 679/052244, 679/052418, 679/052516, 679/072520), 37351-16-N (18/202332, 18/521505, 18/945979, 26/F65163, 679/032423, 679/032504, 679/052201, 679/062466, 679/062504, 679/072521, 679/122251), 37351-18-N (18/203333, 18/531506, 18/946980, 18/971215, 26/F65546, 679/022329, 679/022516, 679/032430, 679/062206, 679/062505, 679/072522), 37351-20-N (18/231334, 18/541507, 18/952981, 26/F65164, 26/F65547, 679/032431, 679/062230, 679/072501, 679/122202), 37351-22-N (18/233335, 18/953982, 26/F65548, 679/062233, 679/092111, 679/122210), 37351-24-N (18/238336, 18/956983, 26/F65549, 679/042415, 679/072203, 679/112242), 37351-26-N (18/204337, 18/947984, 26/F65166, 26/F65550, 679/022330, 679/042416, 679/062207), 37351-28-N (18/234338, 18/954985, 26/F65551, 679/022331, 679/042423, 679/072204), 37351-30-N (18/205339, 18/948986, 26/F65552, 679/042424, 679/072205, 679/122209), 37351-32-N (18/235340, 18/955987, 26/F65553, 679/042425, 679/062234), 37351-34-N (18/206341, 18/491108, 26/F65554, 679/012306, 679/042426, 679/062208), 37351-36-N (18/239342, 18/571109, 18/571503, 26/F65555, 679/022324, 679/052401, 679/062209), 37351-38-N (18/230679, 18/501110, 18/862696, 679/052402, 679/122252), 37351-40-N (147/15088L, 18/207343, 18/506128, 18/511111, 679/052411), 37351-42-N (18/581112, 679/032515), 37351-44-N (18/591113, 679/022511), 37351-46-N (18/601114), 37351-48-N (18/611115, 679/032517), 37351-50-N (18/513248, 18/621116, 18/912703, 679/032518, 679/062508), 37351-55-N (18/652407, 679/032519), 37351-60-N (18/662408), 37351-65-N (679/022512, 679/052236), 37351-70-N (18/631117, 679/052237), 37351-75-N (18/641118, 679/052238), 37351-80-N (679/052239, 679/072406), 37351-85-N (679/052240). 2. Article Number (Lot Numbers): 21241-5 (770/201905), 21241-7 (770/201906), 21242-7 (770/201901), 21243-10 (770/201901), 21244-9 (770/201905). 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: 12,059 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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