Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. Product is used for Orthopedic surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. Product is used for Orthopedic surgery.
Brand
Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia is recalling Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile, Portland Orthopaedics Inc due to Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026