Hip Prosthesis as a component of Primaloc Cementless/Collarless 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-0567-03
- Quantity
- 105
- 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 # 111-0917, Lot # OD-22372. Catalog # 111-1015, Lot # OD-21589, OD-21589-1 Catalog # 111-1017, Lot # OD-23209. Catalog # 111-1019, Lot # OD-23235. Catalog # 111-1115, Lot # OD-22050. Catalog # 111-1117, Lot # OD-23205, OD-23205-1, OD-23298. Catalog # 111-1119, Lot # OD-22846, W002952, OD-23222. Catalog # 111-1217, Lot # OD-23207, OD-23208, OD-23299. Catalog # 111-1219, Lot # OD-22847, OD-20859-1, OD-23230, OD-22847-1. Catalog # 111-1221, Lot # OD-23254, OD-23249, Catalog # 111-1223, Lot # OD-18165, W002524. Catalog # 111-1319, Lot # OD-23231, OD-23231-1. Catalog # 111-1321, Lot # OD-23247. Catalog # 111-1421, Lot # OD-23250, OD-23255. Catalog # 111-1423, Lot # OD-23256. Catalog # 111-1425, Lot # OD-20837-1, W002683. Catalog # 111-1625, Lot # OD-21873, OD-19626-1, OD-22537.
Root Cause
Other
Action Taken
Consignees were notified on 12/26/2002 via telephone and e-mail.