Recall of FR.O.H. Calcaneus Repair System Due to MRI Safety Concerns
I.T.S. GmbH is voluntarily recalling 4 units of the FR.O.H. Calcaneus Repair System because updated MRI safety testing shows higher temperature increases than previously indicated.
What this fda recalls alert tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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Recall of FR.O.H. Calcaneus Repair System
What Happened
I.T.S. GmbH is conducting a voluntary recall of the FR.O.H. Calcaneus Repair System due to updated MRI safety testing that demonstrates higher RF-induced temperature increases under certain MRI conditions than what was previously reflected in the Instructions for Use.
Which Products Are Affected
The affected product is the FR.O.H. Calcaneus Repair System, specifically the Anterolateral Calcaneus Plate with Article Number 21064-60. The recall involves Lot Numbers 679/012318 and 679/0722100, with a total of 4 units distributed nationwide in the United States, including 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, and W. The official recall number is Z-1595-2026.
What You Should Do
Consumers should check with the recalling firm, I.T.S. GmbH, for instructions, as the recall was initiated via e-mail. For returns or refunds, contact the firm at their address: Autal 28, Lasnitzhohe, Austria.
Why This Matters
This recall addresses potential safety risks associated with medical devices during MRI procedures, which could affect patient health and underscores the importance of accurate safety information in medical products.
Source
According to the FDA recall notice with number Z-1595-2026.
Source: FDA Official Notice