Recall Z-2145-2014 ยท HET Laparoscope, Gynecologic (And Accessories)
Market-Tiers Inc
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.
| Date | Aug 2, 2014 (initiated Jul 16, 2014) |
| Status | Terminated |
| Reason | Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. |
| Root cause | Labeling Change Control |
| Action | The recalling firm issued a letter dated 7/16/14 via Federal Express requesting the customer destroy the incorrect IFU and replace it with the corrected version. |
| Quantity | 100 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091010 | TROKAMED MORCELLATOR Trokamed GmbH, Mar 1, 2011 |