FDA Recall of Pelvic Reconstruction System by I.T.S. GmbH
I.T.S. GmbH is voluntarily recalling 11 units of its Pelvic Reconstruction System due to updated MRI safety testing showing potential risks.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 9, 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 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 the Pelvic Reconstruction System because updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). This is a voluntary, firm-initiated recall classified as Class II.
Which Products Are Affected
The affected products are:
- Fixation Screw with Article Number: 70312 and Lot Number: 26/F65133.
- Spike short with Article Number: 70314 and Lot Number: 86/619736.
A total of 11 units are involved in this recall. The products were 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 official recall number is Z-1600-2026.
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. No specific return or refund details are provided in the recall information.
Why This Matters
This recall addresses potential safety risks related to MRI procedures, which could affect the health of users of the Pelvic Reconstruction System. It highlights the importance of accurate medical device labeling for patient safety.
Source
Attribution: FDA. For more information, visit the FDA website at an official FDA link such as https://www.fda.gov (based on standard FDA resources).
Original source: FDA Official Notice ↗
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