FDA DevicesClass II
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Ca...
Published: April 1, 2026Recall ID: Z-1595-2026Category: devicesCountry: US
Reason for Recall / Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Product Description & Identification
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Additional Source Details
| Field | Value |
|---|---|
| City | Lasnitzhohe |
| Event id | 98341 |
| Address 1 | Autal 28 |
| Code info | Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100). |
| Postal code | N/A |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 4 units |
| 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260123 |
| Initial firm notification | |
| Center classification date | 20260320 |
Overview
- Recalling FirmI.T.S. GmbH
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.