EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 R
FDA device recall Z-2171-2014 · posted 2014-08-08 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic
- Action taken
- Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 2
- Distribution
- Distribution to Florida and South Carolina
- Date initiated
- 2014-06-02
- Date posted
- 2014-08-08
- Date terminated
- 2014-08-08
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOWRIST STAPLER SYSTEM (K113706) | Intuitive Surgical, Inc. | 2012-10-17 |