Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
FDA device recall Z-0569-03 · posted 2003-02-25 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Action taken
- Consignees were notified on 12/26/2002 via telephone and e-mail.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 14
- Distribution
- TX and Japan
- Date initiated
- 2002-12-26
- Date posted
- 2003-02-25
- Date terminated
- 2003-04-22
- Location
- Draper, UT
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