LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is u
FDA device recall Z-1819-2009 · posted 2009-08-23 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Products were mispackaged.
- Action taken
- All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 16 units
- Distribution
- Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
- Date initiated
- 2009-01-22
- Date posted
- 2009-08-23
- Date terminated
- 2012-02-07
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW, INC. REVISION KNEE SYSTEM (K043440) | Smith & Nephew, Inc. | 2005-02-18 |