Recall Z-0395-2010 ยท GDW Staple, Implantable
Surgical Devices/Covidien
Remote Control Unit with Wire, product code RCW100.
| Date | Nov 23, 2009 (initiated Sep 23, 2009) |
| Status | Terminated |
| Reason | Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763. |
| Quantity | 371 units |
| Distribution | The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020343 | SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL Power Medical Interventions, Inc., Apr 10, 2002 |