FDA Device recall Z-1597-2026
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook 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-1597-2026 |
| 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
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
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 | 1 Article number (Lot Numbers): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211,…1 Article number (Lot Numbers): 21112-7 (643/0549), 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), 21113-9 (643/072320). 2. Article number (Lot Numbers): 21111-6 (643/032306, 643/072319, 643/112201), 21111-8 (643/032318), 21111-12 (643/032305). |
|---|
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-1597-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.