FDA Recall of Olecranon Plates by I.T.S. GmbH
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 recalls alert 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert 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 alerts 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 recalls advisory 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 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.
Source: FDA Official Notice