Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power Extender Straight with Integrated Controls Reconditioned, product code PES200RC.
Recall
- Recall Number
- Z-0399-2010
- Event Number
- 53694
- Firm
- Surgical Devices/Covidien
- FEI Number
- 1219930
- Product Code
- GDW
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 23, 2009
- Posted
- November 23, 2009
- Terminated
- March 8, 2010
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908
Description
Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power Extender Straight with Integrated Controls Reconditioned, product code PES200RC.
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.
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.
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.
343 units