I.T.S. GmbH recalls Pilonplate with Angular Stability

Recalling company

I.T.S. GmbH

Product

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.

Reason

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 23, 2026

Reported

Apr 1, 2026

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.

Status

Ongoing

Quantity

101 units

Lot / codes

1. Article Number (Lot Numbers): 21311-11 (26/F62573), 21311-15 (26/F65048, 26/F67521), 21311-7 (26/F66165, 26/F67825), 21312-11 (26/F65049, 26/F67826), 21312-15 (26/F66166), 21312-7 (26/F65643, 26/F67827). 2. Article Number (Lot Numbers): 21094-10 (643/032304, 643/082309), 21094-4 (643/0572, 643/0571), 21094-6 (643/112202), 21094-8 (643/012309). 3.Article Number (Lot Numbers): 21093-4 (679/032311, 679/112331), 21093-6 (679/112332).

Company location

Lasnitzhohe

Recall type

Voluntary: Firm initiated

Recall number

Z-1596-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1596-2026 in the FDA Enforcement Report. Also see FDA recall press releases.