Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI
FDA device recall Z-1995-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Portland Orthopaedics Pty, Ltd.
- Reason for recall
- Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
- Action taken
- Stocks were pulled from U.S. consignees on or before 1/11/08. Consignee and implanting surgeon letters dated 6/20/08 were sent advising of the issue and recommending patient monitoring. For assistance, contact Portland Orthopaedics at 1-810-329-3348.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 2403 of all products
- Distribution
- Nationwide.
- Date initiated
- 2008-01-11
- Date posted
- 2008-09-18
- Date terminated
- 2009-11-12
- Location
- Kogarah, Australia
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (K032641) | Portland Orthopaedics Pty. , Ltd. | 2004-01-20 |
| THE MARGRON HIP REPLACEMENT SYSTEM (K992815) | Portland Orthopaedics Pty. , Ltd. | 2000-02-07 |