Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Margron DTC Hip Replacement System; Margron hip - Femoral neck A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-654-000. Product is used for Orthopedic surgery.

FDA Recall Z-1934-2008 · Posted 2008-09-18

Recalling FirmPortland Orthopaedics Pty, Ltd.
Recall StatusTerminated
Product CodeMEH
Date Initiated2008-01-11
Date Terminated2009-11-12
Product Quantity2403 of all products

Reason for Recall

Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032641MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEMPortland Orthopaedics Pty. , Ltd. · 2004-01-20K992815THE MARGRON HIP REPLACEMENT SYSTEMPortland Orthopaedics Pty. , Ltd. · 2000-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑