FDA Medical devices recall ·
I.T.S. Fibula Plate PROlock with Angular Stability with the below… recall
- Recall number
- Z-1601-2026
- Date
- (initiated January 23, 2026)
- Company / brand
- I.T.S. GmbH
Autal 28, Lasnitzhohe, Austria - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 869 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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), 2160
Distribution
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.
States: Alabama Arizona California Colorado Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana Nebraska New Jersey New Mexico Nevada Ohio Oklahoma Pennsylvania South Carolina Texas West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1601-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.