Z-2145-2014 Class II Terminated

Recalled by Market-Tiers Inc — Lenexa, KS

Recall Details

Product Type
Devices
Report Date
December 3, 2014
Initiation Date
July 16, 2014
Termination Date
May 11, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

Product Description

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 for Recall

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

Distribution Pattern

Nationwide Distribution.

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