I.T.S. GmbH Clavicula Plate Recall Over MRI Safety Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
I.T.S. GmbH is voluntarily recalling 322 units of various Clavicula 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 "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.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
I.T.S. GmbH is recalling certain Clavicula plates because updated MRI safety testing revealed higher RF-induced temperature increases under specific MRI conditions than what was previously stated in the Instructions for Use (IFU). This is a Class II recall initiated voluntarily by the firm.
Which Products Are Affected
The affected products include the following Clavicula plates with their associated article numbers and lot numbers: 1. Anterior Clavicle Plate, Medial with article numbers 21116-8 (Lot: 679/092230), 21117-10 (Lots: 679/032313, 679/092231), 21118-10 (Lots: 679/032314, 679/072047, 679/092232). 2. Clavicle Plate with article numbers 21121-6 (Lots: 679/092236, 679/092329), 21121-8 (Lot: 679/052226). 3. Clavicle Plate, 3.5mm with article numbers 21122-10 (Lots: 00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (Lots: 00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (Lots: 00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Clavicle Plate, Lateral with article numbers 21123-4 (Lots: 00/0810-06, 679/052014, 679/062216), 21124-4 (Lots: 679/042333, 679/062217, 679/072346), 21127-6 (Lot: 679/052228), 21128-6 (Lot: 679/042341). A total of 322 units are affected, distributed nationwide in the United States, specifically in states including 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 official recall number is Z-1593-2026.
What You Should Do
Consumers who have received an e-mail notification from I.T.S. GmbH should follow the instructions provided in that notification. Contact the recalling firm at I.T.S. GmbH, Autal 28, Lasnitzhohe, Austria, for further information on returns or refunds.
Why This Matters
This recall addresses potential safety risks associated with MRI procedures, which could affect patients using these devices and underscores the importance of accurate medical device labeling for patient safety.
Source
This information is from the FDA. For more details, visit the FDA website at https://www.fda.gov/ and search for recall number Z-1593-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.