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Terminated

Hip Prosthesis as a component of Primaloc Cemented Hip System.

FDA Recall Z-0568-03 · Posted 2003-02-25

Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Date Initiated2002-12-26
Date Terminated2003-04-22
Product Quantity41

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962448PRIMALOC CEMENTED HIP SYSTEMOrtho Development Corp. · 1996-09-19

Official Source

View FDA Recall →

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

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