Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product cod
FDA device recall Z-0393-2010 · posted 2009-11-23 · Terminated
Recall details
- Recalling firm
- Surgical Devices/Covidien
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 38,058 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, Po
- Date initiated
- 2009-09-23
- Date posted
- 2009-11-23
- Date terminated
- 2010-03-08
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) (K032701) | Power Medical Interventions, Inc. | 2003-09-30 |