I.T.S. LRS Locking System Recall Due to MRI Safety Concerns
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I.T.S. GmbH is voluntarily recalling 176 units of its Locking Reconstruction System devices because updated MRI safety testing showed 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, cpsc, Devices.
What Happened
I.T.S. GmbH is recalling certain Locking Reconstruction System devices due to updated MRI safety testing that demonstrates higher RF-induced temperature increases under specific MRI conditions than what was previously reflected in the Instructions for Use.
Which Products Are Affected
The affected products are part of the I.T.S. LRS (Locking Reconstruction System) and include the following:
- DFL (Distal Femur Locking) Distal Femur Plate with Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13.
- PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate with Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12.
- PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate with Article Numbers: 21325-4, 21325-7. The recall involves 176 units with specific lot numbers, such as 21301-5 (26/F62569), and distribution occurred nationwide in the United States, including states like 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-1603-2026.
What You Should Do
Consumers who have the affected products should follow the initial firm notification, which was sent via email, and contact the recalling firm, I.T.S. GmbH, for further instructions on the voluntary recall.
Why This Matters
This recall addresses potential safety risks during MRI procedures, ensuring that medical devices meet updated safety standards to prevent possible health issues for patients.
Source
FDA recall notice with recall number Z-1603-2026.
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 (1,632 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.