FDA Recall of Volar Radius Plate by I.T.S. GmbH
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 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.
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 ↗
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 (1,390 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.