Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
FDA Recall Z-0569-03 · Posted 2003-02-25
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Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Date Initiated2002-12-26
Date Terminated2003-04-22
Product Quantity14
Reason for Recall
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Firm Action
Consignees were notified on 12/26/2002 via telephone and e-mail.
Root Cause
Other
Distribution Pattern
TX and Japan
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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