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Market-Tiers Inc recalls Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011,
Recalled December 3, 2014 · FDA recall Z-2145-2014 · Market-Tiers
Hazard
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. · FDA Class II
Units
100 units
Sold at
Nationwide Distribution.
Description
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
Product
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.
Manufacturer(s)
Market-Tiers Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →