Hip Prosthesis as a component of Primaloc Cementless/Collared 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-0566-03
- Quantity
- 78
- 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 # 112-0915, Lot # OD-18031, W003152, WO#003152. Catalog # 112-0917, Lot # OD-19103-1, OD-20567, W0#003109. Catalog # 112-1015, Lot # OD-19038, W0#003155. Catalog # 112-1017, Lot # OD-17403. Catalog # 112-1115, Lot # WO#003045. Catalog # 112-1117, Lot # OD-23210, OD-23211. Catalog # 112-1119, Lot # OD-23232. Catalog # 112-1217, Lot # OD-23206. Catalog # 112-1219, Lot # OD-23233. Catalog # 112-1221, Lot # OD-23252 Catalog # 112-1223, Lot # OD-17321, W003725, WO#003350. Catalog # 112-1319, Lot # OD-20572, OD-20867-1, OD-23234, OD-23234-1, OD-23246. Catalog # 112-1321, Lot # OD-23253. Catalog # 112-1421, Lot # OD-23248, OD-23248-1, OD-23251, OD-23251-1. Catalog # 112-1425, Lot # OD-21874. Catalog # 112-1623, Lot # OD-21147-1. Catalog # 112-1625, Lot # W0#003130, WO#003139.
Root Cause
Other
Action Taken
Consignees were notified on 12/26/2002 via telephone and e-mail.