Z-2145-2014Class II

Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model...

Name: Z-2145-2014 Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model...
Creator: Market-Tiers Inc
Published: 2014-07-16
License: https://open.fda.gov/license/

MARKET-TIERS, Inc. d/b/a Blue Endo / initiated 2014-07-16 / Terminated / root cause: labeling and UDI

FDA source

Market-Tiers Inc began a recall of Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit... on 2014-07-16. FDA classified it as Class II and gives the reason as "Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2145-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-16
Posted: 2014-08-02
Terminated: 2015-05-11
Recalling firm: MARKET-TIERS, Inc. d/b/a Blue Endo
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.
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
Root cause tag: labeling and UDI
FDA 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 in commerce: 100 units
Distribution: Nationwide Distribution.
Product codes and lots: Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 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, 7010201-023, 7010201-024, 7686200-010, 7010201-025, 7686200-002, 7686200-003, 7686200-006, 7686200-004, 7686200-007, 7686200-008, 7686200-024, 7686200-009, 7686200-017, 7686200-011, 7686200-012, 7686200-013, 7686200-014, 7686200-015, 7686200-016, 7686200-018, 7686200-019, 7686200-020, 7686200-023, 7686200-025, 8037400-001, 8037400-002, 8037400-006, 8037400-004, 8037400-012, 8037400-005, 8037400-007, 8037400-011, 8037400-018, 8037400-008, 8037400-010, 8037400-013, 8037400-014, 8037400-017, 8037400-003, and 8374200-008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2145-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2145-2014	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-21

Product code HET

K091010Class IITrokamed MorcellatorTrokamed GmbH / cleared 2011-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)