Z-1601-2026 Class II Ongoing
FDA device recall Z-1601-2026 was initiated by I.T.S. GmbH on January 23, 2026 and is designated Class II. Reason for recall: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). The recall status is ongoing. Affected quantity: 869 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- January 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 869 units
Product Description
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distribution Pattern
US Nationwide distribution 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, W.
Code Information
1. Article Number (Lot Numbers): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305, 643/072333), 21602-7 (643/072332, 643/082305), 21602-8 (43/0405, 643/012305), 21603-3 (643/072331, 643/082306), 21603-4 (643/102214, 643/102206, 643/072302, 643/022313, 643/032310), 21603-5 (643/072335, 643/122308), 21603-6 (643/022309, 643/072305, 643/072311, 643/122309), 21603-7 (643/072337, 643/082313), 21603-8 (643/072312, 643/122204). 2. Article Number (Lot Numbers): 21225-4 (768/20894, 26/F65041, 26/F66149, 679/092305, 679/022430, 26/F705141, 26/F72362, 26/F73634), 21225-6 (768/20895, 768/20039, 26/F65042, 26/F66150, 26/F66499, 679/092321, 26/F705161, 679/062459, 26/F70516, 26/F73635), 21225-8 (768/20896, 26/F65635, 26/F66500, 26/F70515), 21225-10 (26/F66497), 21225-12 (26/F66498, 679/012438), 21226-4 (26/F65043, 26/F66152, 26/F66501, 26/F70521, 26/F705211, 679/012412, 679/062306, 679/092306, 768/20897, 768/208978), 21226-6 (26/F35433, 26/F65044, 26/F66502, 26/F70522, 26/F705221, 679/062307, 679/092307, 768/20898), 21226-8 (26/F66503, 679/012413, 768/20045, 768/20899), 21226-10 (26/F66151), 21226-12 (26/F66148, 679/012411). 3. Article Number (Lot Numbers): 21601-5 (643/012302, 643/072323), 21601-6 (643/072326, 770/201904), 21601-7 (643/012303, 643/022308, 643/0647, 643/072315, 643/072327, 643/082303), 21601-8 (643/072328, 643/072329), 21601-10 (643/022312, 643/082301, 643/082302), 21601-12 (26/F70342), 21601-14 (26/F70343), 21601-16 (26/F70344).