Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
FDA device recall Z-0086-2010 · posted 2009-10-28 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
- Action taken
- Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWY
- Quantity affected
- 23
- Distribution
- AZ, CA, FL, MA, MI. No military, government or foreign distribution.
- Date initiated
- 2009-04-29
- Date posted
- 2009-10-28
- Date terminated
- 2010-05-25
- 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 |
|---|---|---|
| PIVOT BIPOLAR FEMORAL HEAD (K050966) | Ortho Development Corp. | 2005-07-07 |