FDA Recall
Terminated
Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
Recall: Z-0339-04
·
Initiated September 19, 2003
Recall
- Recall Number
- Z-0339-04
- Event Number
- 27848
- Firm
- Plus Orthopedics
- FEI Number
- 3001237832
- Product Code
- LWJ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 19, 2003
- Posted
- January 14, 2004
- Terminated
- March 3, 2005
- Address
- 6055 Lusk Blvd, San Diego, CA, 92121
Description
Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
Reason
Design Change
Action
Notify all implanting physicians of the removal and weight restrictions, and to evaluate thier patients for adherence to the weight restriction.
Distribution
CA, AZ, NV, NV, CO
Quantity
53