Recall of I.T.S. GmbH Foot Locking Plates and Hallux Osteotomy Plates
I.T.S. GmbH is voluntarily recalling 15,517 units of certain medical devices due to updated MRI safety testing showing higher temperature increases than previously stated.
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.
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Recall of I.T.S. GmbH Foot Locking Plates and Hallux Osteotomy Plates
What Happened
The recall is due to updated MRI safety testing that demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Which Products Are Affected
The affected products include: 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw with article numbers 37303-10 through 37303-30; 2. FLS - Foot Locking Plates System, Cortical Screw with article numbers 32271-10 through 32271-34; 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw with article numbers 37304-10 through 37304-24; 4. FLS - Foot Locking Plates System, FLS Plate, Curved with article number 21413-6; 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape with article number 21431-ME; 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape with article numbers 21482 and 21483; 7. FLS - Foot Locking Plates System, FLS Plate, Straight with article number 21421-5; 8. FLS - Foot Locking Plates System, Stabilization Screw with article numbers 37241-10 through 37241-30; and 9. HOL - Hallux Osteotomy Locking Plate with article numbers 21015-08 and 21015-09. A total of 15,517 units are affected, with specific lot numbers provided for each article number. These 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, WV, and others. The official recall number is Z-1605-2026.
What You Should Do
Consumers should contact the recalling firm, I.T.S. GmbH, for instructions regarding the affected products. The firm is located at Autal 28, Lasnitzhohe, Austria.
Why This Matters
This recall ensures that medical devices meet updated safety standards for MRI procedures, potentially preventing health risks associated with temperature increases during scans.
Source
FDA Recall Notice: Z-1605-2026
Source: FDA Official Notice