Home / Recalls / I.T.S. GmbH / Z-1602-2026

Z-1602-2026 Class II Ongoing

Recalled by I.T.S. GmbH — Lasnitzhohe

Recall Details

Product Type
Devices
Report Date
April 1, 2026
Initiation Date
January 23, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,059 units

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.

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).

Distribution Pattern

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.

Code Information

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).

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