Recall Z-2145-2014— Market-Tiers Inc
Class II · Terminated
Class II FDA medical device recall by Market-Tiers Inc, initiated 2014-07-16, terminated 2015-05-11. It names one FDA 510(k) clearance: K091010. 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.. Reason: Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications..
- Recalling firm
- Market-Tiers Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-16
- Terminated
- 2015-05-11
- Firm location
- Lenexa, KS, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.