Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The End
FDA device recall Z-0822-2016 · posted 2016-02-18 · Terminated
Recall details
- Recalling firm
- Medtronic
- Reason for recall
- Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
- Action taken
- Medtronic sent an Urgent Medical Device Recall letters dated December 2 2015 and an Updated Urgent Medical Device Recall letter dated January 13, 2016, to affected customers, via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473. For questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 2711 kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Ch
- Date initiated
- 2015-12-02
- Date posted
- 2016-02-18
- Date terminated
- 2019-07-18
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS (K111825) | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-10-25 |