Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Deve
FDA device recall Z-1993-2009 · posted 2009-09-09 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891).
- Action taken
- Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 13 units
- Distribution
- Worldwide -- US (states of FL and TX) and Japan.
- Date initiated
- 2009-05-29
- Date posted
- 2009-09-09
- Date terminated
- 2010-05-11
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHO DEVELOPMENT BALANCED KNEE SYSTEM (K994370) | Ortho Development Corp. | 2000-03-24 |