[pending] FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Artic
Pending LLM rewrite. Source: FDA_DEVICE Z-1595-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
The recalled product
- Product
- FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
- Manufacturer
- I.T.S. GmbH
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Article Number (Lot Numbers): 21064-60 (679/012318
- 679/0722100).
Distribution
Distributed nationwide across the United States.
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