I.T.S. LRS Locking System Recall Due to MRI Safety Concerns

FDA Recalls medium FDA · · United States

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 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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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.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.