Medical Device Recall: 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, 37351-1
I.T.S. GmbH · January 23, 2026
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Product 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.
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.
States Affected
NATIONWIDE
Quantity Affected
12,059 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1602-2026
Status: ongoing
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