FDA Device recall Z-1595-2026
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus 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-1595-2026 |
| 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
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
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): 21064-60 (679/012318, 679/0722100). |
|---|
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-1595-2026%22
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