Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Enforcement
- Recall Number
- Z-1594-2026
- Event ID
- 98341
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- I.T.S. GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 1, 2026
- Initiation Date
- January 23, 2026
- Classification Date
- March 20, 2026
- Address
- Autal 28, Lasnitzhohe, N/A, Austria
Description
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366, 26/F65626, 26/F656261, 26/F66145, 26/F661451, 26/F66496, 26/F66905, 26/F669051, 26/F73497, 679/012439, 679/022450), 211341-7 (26/F63367, 26/F65627, 26/F66146, 26/F66906, 679/012440), 21134-4 (768/18758, 768/19642), 21134-5 (778/201904), 21135-4 (26/F67801, 768/21382), 21136-4 (26/F65629, 26/F66907, 26/F67802, 26/F70071, 768/21383), 21136-5 (770/101901), 21136-7 (26/F65039, 26/F65630), 21137-4 (26/F65631, 26/F67804, 768/21384), 21137-7 (26/F65040), 21138-4 (26/F65633, 26/F66908, 26/F67806), 21139-4 (26/F65634, 26/F67807, 768/21386).
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.
292 units