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Terminated

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.

FDA Recall Z-2145-2014 · Posted 2014-08-02

Recalling FirmMarket-Tiers Inc
Recall StatusTerminated
Product CodeHET
Date Initiated2014-07-16
Date Terminated2015-05-11
Product Quantity100 units

Reason for Recall

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

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091010TROKAMED MORCELLATORTrokamed GmbH · 2011-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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