FDA Device recall Z-1594-2026
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate by I T S, citing updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1594-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-23 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | I T S |
| Distribution | US |
Product
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.
Reason
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Identifiers
| code_info | Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366,…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1594-2026%22
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