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Terminated

Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.

FDA Recall Z-1186-03 · Posted 2003-08-28

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeMRA
Date Initiated2003-08-18
Date Terminated2004-01-29
Product Quantity133 units

Reason for Recall

Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.

Firm Action

Distributors returned thier stock after May 8, 2003

Root Cause

Other

Distribution Pattern

nationwide

Official Source

View FDA Recall →

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

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