Hip Prosthesis as a component of Primaloc Cemented Hip System.
This recall has been terminated (originally issued February 25, 2003).
- Company
- Ortho Development Corporation
- Recall Initiated
- December 26, 2002
- Posted
- February 25, 2003
- Terminated
- April 22, 2003
- Recall Number
- Z-0568-03
- Quantity
- 41
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Distribution
TX and Japan
Lot / Code Info
Catalog # 114-0917, Lot # OD-18030-5, W003600, W003601, W003602. Catalog # 114-1017, Lot # OD-18563, OD-18563-1, OD-23190, OD-23191, OD-23221. Catalog # 114-1219, Lot # OD-23192, OD-23192-1, OD-23193, OD-23194. Catalog # 114-1421, Lot # OD-17306, OD-17412. Catalog # 114-1623, Lot # W0#003264, W003614.
Root Cause
Other
Action Taken
Consignees were notified on 12/26/2002 via telephone and e-mail.
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