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Terminated

Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-647-000. Product is used for Orthopedic surgery.

FDA Recall Z-1945-2008 · 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.

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