Drug recall
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate…
FDA recall event 98341 · Class II · I.T.S. GmbH
Key facts
| Event ID | 98341 |
|---|---|
| Recall numbers | Z-1592-2026, Z-1593-2026, Z-1594-2026, Z-1595-2026, Z-1596-2026, Z-1597-2026, Z-1598-2026, Z-1599-2026, Z-1600-2026, Z-1601-2026, Z-1602-2026, Z-1603-2026 and 5 more |
| Recalling firm | I.T.S. GmbH |
| Product type | Devices |
| Products | 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…, Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2…, Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate…, 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…, FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization… and 12 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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). |
| Initiation date | Jan 23, 2026 |
| Report date | Apr 1, 2026 |
| City | Lasnitzhohe |
| Country | Austria |
| FEI number | 3004369035 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: