Reported Dec 3, 2014 · Terminated

Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011,…

Market-Tiers Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Market-Tiers Inc · 8097 Flint St · Lenexa, KS · 66214-3335

Is this the product you have?

  • 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.
Lot codes and dates
  • Instructions for Use V. 02.08.2012 that was provided with control units
  • bearing the following serial numbers

    100 of 100 codes

    • 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
Amount recalled
100 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 11, 2015 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.