Genesis Uni Articular Inserts
FDA device recall Z-0304-05 · posted 2004-12-14 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
- Action taken
- Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSX
- Quantity affected
- 11,339 units were distributed
- Distribution
- Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South
- Date initiated
- 2004-06-21
- Date posted
- 2004-12-14
- Date terminated
- 2006-02-15
- 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 |
|---|---|---|
| GENESIS UNICOMPARTMENTAL KNEE SYSTEM (K912735) | Smith & Nephew Richards, Inc. | 1991-12-27 |