Recall Z-1844-2012 · GDW Staple, Implantable
Covidien LP
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
| Date | Jun 21, 2012 (initiated May 9, 2012) |
| Status | Terminated |
| Reason | Potential for the sterility barrier to be compromised. |
| Root cause | Package design/selection |
| Action | The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2012 via federal express to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (note: units from affected lots may have been incorporated into Covidien BEST PRACTICE KITS; evaluate kits for affected lots). All affected ROTICULATOR units must be returned. The customers were also instructed to complete and return the attached ROTICULATOR Single Use Stapler Recalled Product Return form via fax to |
| Quantity | 50698 units |
| Distribution | Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA¿A France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K855047 | AUTO SUTURE TITANIUM SURGICAL STAPLES United States Surgical, A Division of Tyco Healthc, Jan 14, 1986 |