I.T.S. GmbH Clavicula Plate Recall Over MRI Safety Concerns
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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 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, cpsc, Devices.
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
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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 (2,217 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.