FDA Recall of Olecranon Plates by I.T.S. GmbH
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I.T.S. GmbH is voluntarily recalling 70 units of Olecranon Plates due to updated MRI safety testing showing higher temperature increases under certain conditions.
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, cpsc, Devices.
FDA Recall of Olecranon Plates
What Happened
I.T.S. GmbH initiated a voluntary recall because updated MRI safety testing revealed 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 Olecranon Hook Plate and Olecranon Plate with Angular Stability. Specific article numbers include: 1. Olecranon Hook Plate with article numbers 21112-7, 21114-5, and 21113-9. 2. Olecranon Plate with article numbers 21111-6, 21111-8, and 21111-12. The recall involves 70 units distributed nationwide in the United States, specifically in states such as 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. Lot numbers for these products are: For 21112-7 (643/0549), for 21114-5 (643/032301, 643/042303, 643/042304, 643/0618, 643/102211, 643/112304), for 21113-9 (643/072320), for 21111-6 (643/032306, 643/072319, 643/112201), for 21111-8 (643/032318), and for 21111-12 (643/032305). The official recall number is Z-1597-2026.
What You Should Do
Consumers who have these products should check if they possess the affected article numbers and lot numbers, and contact I.T.S. GmbH as the recall was initiated via e-mail notification.
Why This Matters
This recall addresses potential safety risks related to MRI procedures, ensuring that medical devices meet updated safety standards to prevent possible health issues.
Source
Attribution: FDA Recall Number Z-1597-2026. For more information, visit the FDA website.
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 (1,622 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.