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Ivoclar A. G Recalls

1 recall on record · November 11, 2015 to November 11, 2015 · Medical Devices

November 11, 2015Medical DevicesFDA

Ivoclar A. G. recalls Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental

Hazard: A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.

Ivoclar A. G Recalls | RecallWatchUSA