Recall of Distal Humeral Plates by I.T.S. GmbH
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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 recall 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,432 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.