Recall of Humeral Head Plate Devices by I.T.S. GmbH
I.T.S. GmbH is voluntarily recalling 292 units of Humeral Head Plate with Angular Stability due to updated MRI safety testing showing higher temperature increases.
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 "medium" 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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What Happened
I.T.S. GmbH is recalling the Humeral Head Plate with Angular Stability because updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.
Which Products Are Affected
The affected products are the Brand Name: Humeral Head Plate with Angular Stability, described as Proximal Humeral Plate. The article numbers include: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, and 21139-4. A total of 292 units are affected, with distribution in the US 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 recall number is Z-1594-2026, and specific lot numbers are associated with each article number as listed in the recall details.
What You Should Do
Consumers who have these devices should contact the recalling firm, I.T.S. GmbH, at their address: Autal 28, Lasnitzhohe, Austria, for further instructions regarding returns or refunds, as the recall was initiated via e-mail.
Why This Matters
This recall addresses potential risks associated with MRI procedures, which could lead to adverse health effects due to the devices' temperature increases, emphasizing the importance of accurate safety information in medical devices.
Source
FDA Recall Notice: Event ID 98341, available through FDA resources.
Source: FDA Official Notice