Recall of HCS Headless Compression Screw System by I.T.S. GmbH
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I.T.S. GmbH is recalling 623 units of the HCS Headless Compression Screw System 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 7, 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 initiated a voluntary recall of the HCS - Headless Compression Screw System because updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than what was previously stated in the Instructions for Use (IFU).
Which Products Are Affected
The affected products are the HCS - Headless Compression Screw System with the following article numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90. A total of 623 units are affected, distributed nationwide in the United States, specifically in the states of 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 recall number is Z-1606-2026, and specific lot numbers are associated with each article number as listed in the recall details.
What You Should Do
Consumers who have these products should contact the recalling firm, I.T.S. GmbH, for further instructions, as the initial notification was made via e-mail. Do not use the product until advised otherwise by the firm.
Why This Matters
This recall affects 623 medical devices distributed across multiple U.S. states, potentially impacting patient safety during MRI procedures due to inaccurate safety information.
Source
Attribution: FDA recall notice with event ID 98341. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,701 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.