Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System.
FDA device recall Z-0566-03 · posted 2003-02-25 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Action taken
- Consignees were notified on 12/26/2002 via telephone and e-mail.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 78
- Distribution
- TX and Japan
- Date initiated
- 2002-12-26
- Date posted
- 2003-02-25
- Date terminated
- 2003-04-22
- 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 |
|---|---|---|
| PRIMALOC CEMENTLESS HIP SYSTEM (K953977) | Ortho Development Corp. | 1996-01-26 |