Z-1985-2008

Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+3, sterile, Portland...

Name: Z-1985-2008 Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+3, sterile, Portland...
Creator: Portland Orthopaedics Pty, Ltd.
Published: 2008-01-11
License: https://open.fda.gov/license/

Portland Orthopaedics Pty., Ltd. / initiated 2008-01-11 / Terminated / root cause: design

FDA source

Portland Orthopaedics Pty, Ltd. began a recall of Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-953. Product... on 2008-01-11. The reason FDA records is "Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1985-2008
Status: Terminated
Initiated: 2008-01-11
Posted: 2008-09-18
Terminated: 2009-11-12
Recalling firm: Portland Orthopaedics Pty., Ltd.
Product: Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-953. Product is used for Orthopedic surgery.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
Root cause tag: design
FDA 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 in commerce: 2403 of all products
Distribution: Nationwide.
Product codes and lots: All lots.

Product code MEH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)