Recall Z-1941-2008 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Portland Orthopaedics Pty, Ltd.
Margron DTC Hip Replacement System; Margron hip - Femoral neck B+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-689-000. Product is used for Orthopedic surgery.
| Date | Sep 18, 2008 (initiated Jan 11, 2008) |
| Status | Terminated |
| Reason | Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 2403 of all products |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |