FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Reason: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

Code information: Lot Number: M1505053

Distribution pattern: Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.