5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balance
FDA device recall Z-1229-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- A component of knee prosthesis was assembled incorrectly.
- Action taken
- E-mail was sent to all agents and distributors on March 19, 2009 with illustrations and instructions on how to detect the upside down assembly and how to correct the problem if detected during surgery. Direct questions to the Ortho Development Corporation by calling 1-801-619-3444.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 368 units
- Distribution
- United States (AZ, FL, OR, TX and UT) and Japan.
- Date initiated
- 2009-03-19
- Date posted
- 2010-04-05
- Date terminated
- 2010-06-30
- 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 MODULAR TIBIAL SYSTEM (K031201) | Ortho Development Corp. | 2003-07-15 |