Recall of Distal Humeral Plates by I.T.S. GmbH

FDA Recalls medium FDA · · United States

I.T.S. GmbH is recalling 12,059 units of Distal Humeral Plates due to updated MRI safety testing showing 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 "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.

Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

I.T.S. GmbH is recalling Distal Humeral Plates 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 include Distal Humeral Plates with Angular Stability, specifically: 1. Cortical Screw, Locking with article numbers such as 37351-10-N, 37351-12-N, up to 37351-85-N, and 2. Humeral Plate, Distal with article numbers 21241-5, 21241-7, 21242-7, 21243-10, and 21244-9. The recall involves 12,059 units distributed nationwide in the United States, including states such as AL, AZ, 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, WV, and territories like BVI and USVI. Specific lot numbers are associated with each article number, as detailed in the recall notice.

What You Should Do

Consumers who have these products should contact the recalling firm, I.T.S. GmbH, as the recall was initiated via E-Mail for further instructions on the voluntary recall.

Why This Matters

This recall is significant because it addresses potential safety risks related to MRI procedures, helping to prevent possible adverse effects from inaccurate safety information in the product instructions.

Source

Attribution: FDA. For more information, refer to FDA recall number Z-1602-2026 on the FDA website.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
I.T.S. GmbH is recalling 12,059 units of Distal Humeral Plates due to updated MRI safety testing showing higher temperature increases than previously indicated.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.