Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
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-0569-03
- Quantity
- 14
- 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 # 115-1015, Lot # W016134, W017080. Catalog # 115-1319, Lot # W016434.
Root Cause
Other
Action Taken
Consignees were notified on 12/26/2002 via telephone and e-mail.
More recalls by Ortho Development Corporation
PS Tibial Insert, REF 163-1XXX
Product Usage:
UHMWPE component used in TKA procedures to serve as a...
Aug 17, 2014