Recall of I.T.S. GmbH Pilon Plates Over MRI Safety Concerns
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I.T.S. GmbH is voluntarily recalling 101 units of specific Pilon plates due to updated MRI safety testing showing higher temperature risks than previously stated.
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.
What Happened
The recall was initiated because updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than what was previously reflected in the Instructions for Use (IFU).
Which Products Are Affected
The affected products include:
- Pilonplate with Angular Stability, specifically:
- Anterolateral Tibia Plate with Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7.
- Pilon Plate 4mm with Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8.
- Pilon Plate, Small with Article Numbers: 21093-4, 21093-6. Lot numbers for these products are as follows:
- For 21311-11: 26/F62573
- For 21311-15: 26/F65048, 26/F67521
- For 21311-7: 26/F66165, 26/F67825
- For 21312-11: 26/F65049, 26/F67826
- For 21312-15: 26/F66166
- For 21312-7: 26/F65643, 26/F67827
- For 21094-10: 643/032304, 643/082309
- For 21094-4: 643/0572, 643/0571
- For 21094-6: 643/112202
- For 21094-8: 643/012309
- For 21093-4: 679/032311, 679/112331
- For 21093-6: 679/112332 A total of 101 units are affected, distributed nationwide in the United States, including 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. The official recall number is Z-1596-2026.
What You Should Do
Consumers who have these products should follow the firm's initial notification via E-Mail and contact I.T.S. GmbH for further instructions on the voluntary recall.
Why This Matters
This recall highlights potential risks in medical devices during MRI procedures, which could affect patient safety if not addressed.
Source
FDA Recall Number: Z-1596-2026. For more information, visit the 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 (1,732 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.