FDA Recall of Volar Radius Plate by I.T.S. GmbH
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The FDA has announced a recall of 220 units of Volar Radius Plate with Angular Stability due to updated MRI safety concerns.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 9, 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 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 read it 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 notices 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 recall 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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FDA Recall of Volar Radius Plate by I.T.S. GmbH
What Happened
The recall was initiated because updated MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than previously indicated in the Instructions for Use (IFU).
Which Products Are Affected
The affected products are the Volar Radius Plate with Angular Stability, specifically the Radius Plate PROlock II. The article numbers include: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, and 21036-3. A total of 220 units are involved, with lot numbers such as 679/042207 for 21031-3 and others as detailed in the code info. These products were distributed nationwide in the United States, specifically in 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 recall number is Z-1592-2026.
What You Should Do
Consumers who have these products should contact the recalling firm, I.T.S. GmbH, for further instructions, as the recall was initiated via e-mail notification.
Why This Matters
This recall addresses potential safety risks with medical devices during MRI procedures, which could affect patient safety in healthcare settings.
Source
Attribution: FDA. For more information, refer to the FDA recall notice at the official FDA website.
Original source: FDA Official Notice ↗
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