I.T.S. GmbH Fibula Plate Recall
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I.T.S. GmbH is voluntarily recalling 869 units of various fibula 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 "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, fda, Devices.
What Happened
I.T.S. GmbH is recalling certain medical devices because updated MRI safety testing has demonstrated higher RF-induced temperature increases under specific MRI conditions than what was previously stated in the Instructions for Use (IFU).
Which Products Are Affected
The affected products include:
- Distal Tubular Plate with Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8, and their corresponding lot numbers.
- Fibula Plate 3.5mm with Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12, and their corresponding lot numbers.
- Universal Tubular Plate with Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16, and their corresponding lot numbers. A total of 869 units are affected, distributed nationwide in the United States, including states such as AL, AZ, 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, WV, and territories like BVI and USVI. The official recall number is Z-1601-2026.
What You Should Do
Consumers who have these products should contact the recalling firm, I.T.S. GmbH, as the recall was initiated via e-mail, for further instructions on the voluntary recall.
Why This Matters
This recall highlights potential safety risks with medical devices during MRI procedures, which could affect patient health if not addressed, emphasizing the importance of accurate safety information in medical products.
Source
FDA Recall Notice: https://www.fda.gov (attribution to FDA, Recall Number: Z-1601-2026)
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 (1,676 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.