I.T.S. Screw System Recall Due to MRI Safety Concerns
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I.T.S. GmbH is voluntarily recalling 5,568 units of various screw systems and washers because updated MRI safety testing revealed higher temperature increases 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 "high" 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 read it 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 notices 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 recall 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 medical devices after updated MRI safety testing showed 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 include:
- Cancellous Screw, Cannulated with article numbers such as 31404-16, 31404-18, up to 31404-80, and others like 31457-30 to 31457-60.
- Cortical Screw, Cannulated with article numbers such as 31357-20 to 31357-70.
- Washer with article number 36851.
- Washer, Concave with article numbers 36432, 36653, and 36732.
- Washer, Flat with article numbers 36431, 36651, 36653, and 36731. Specific lot numbers are associated with these article numbers, and a total of 5,568 units are affected. The products were 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, USVI, WV, and W. The recall number is Z-1599-2026.
What You Should Do
Consumers and healthcare providers who have the affected products should contact I.T.S. GmbH for instructions, as the recall was initiated via e-mail. For returns or refunds, reach out to the recalling firm at their address: Autal 28, Lasnitzhohe, Austria.
Why This Matters
This recall highlights potential risks associated with medical devices during MRI procedures, emphasizing the need for accurate safety information to prevent possible health issues in 5,568 affected units.
Source
FDA Recall Notice: event ID 98341, recall number Z-1599-2026
Original source: FDA Official Notice ↗
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