Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011,
FDA device recall Z-2145-2014 · posted 2014-08-02 · Terminated
Recall details
- Recalling firm
- Market-Tiers Inc
- Reason for recall
- Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
- Action taken
- 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
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 100 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-07-16
- Date posted
- 2014-08-02
- Date terminated
- 2015-05-11
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TROKAMED MORCELLATOR (K091010) | Trokamed GmbH | 2011-03-01 |