Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

Reason: Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

Code information: Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 4861300-002, 6283800-002, 6283800-004, 6283800-010, 6283800-023, 6823800-045, 6283800-008, 6283800-011, 6283800-013, 7010201-017, 6283800-014, 6283800-016, 6283800-017, 6283800-019, 6283800-020, 6283800-021, 6283800-022, 6283800-029, 6283800-024, 6283800-026, 6283800-027, 6283800-030, 6283800-031, 6283800-034, 6283800-037, 6283800-038, 6283800-039, 6283800-040, 6283800-042, 6283800-043, 6283800-044, 6283800-046, 6283800-047, 6283800-048, 6283800-049, 6283800-050, 6929500-002, 6929500-003, 6929500-004, 6929500-005, 6929500-006, 6929500-007, 6929500-008, 6929500-010, 7010201-002, 7010201-003, 7010201-005, 7010201-006, 7010201-007, 7010201-008, 7010201-015, 7010201-010, 7010201-013, 7010201-014, 7010201-016, 7010201-019, 7010201-018, 7010201-020, 7010201-021, 7010201-022, 7010201-023, 7010201-024, 7686200-010, 7010201-025, 7686200-002, 7686200-003, 7686200-006, 7686200-004, 7686200-007, 7686200-008, 7686200-024, 7686200-009, 7686200-017, 7686200-011, 7686200-012, 7686200-013, 7686200-014, 7686200-015, 7686200-016, 7686200-018, 7686200-019, 7686200-020, 7686200-023, 7686200-025, 8037400-001, 8037400-002, 8037400-006, 8037400-004, 8037400-012, 8037400-005, 8037400-007, 8037400-011, 8037400-018, 8037400-008, 8037400-010, 8037400-013, 8037400-014, 8037400-017, 8037400-003, and 8374200-008

Distribution pattern: Nationwide Distribution.