Recall of I.T.S. Pelvic Reconstruction System Over MRI Safety Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
I.T.S. GmbH is recalling 46,637 units of its Pelvic Reconstruction 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 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.
Recall of I.T.S. Pelvic Reconstruction System
What Happened
I.T.S. GmbH initiated a voluntary recall 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). This recall is classified as Class II.
Which Products Are Affected
The affected products are various components of the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix), including items such as Anterior Column Plate with article numbers like 21218-16 and 21219-16, Biplanar 2-Column Plate with numbers like 21216-10, and many others listed in the source. A total of 46,637 units are involved, distributed nationwide in the United States across states including AL, AZ, CA, FL, TX, and others. Specific lot numbers are associated with each article number, such as 21218-16 with lots 679/112166.
What You Should Do
Consumers who have these products should contact the recalling firm, I.T.S. GmbH, for further instructions, as the recall was initiated via e-mail notification.
Why This Matters
This recall addresses potential safety risks related to MRI procedures, ensuring that medical devices meet updated safety standards to prevent possible health issues for patients.
Source
Attribution: FDA Recall Number Z-1608-2026. For more information, visit the FDA website.
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 (1,378 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.