Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
This recall has been terminated (originally issued January 14, 2004).
- Company
- Plus Orthopedics
- Recall Initiated
- September 19, 2003
- Posted
- January 14, 2004
- Terminated
- March 3, 2005
- Recall Number
- Z-0339-04
- Quantity
- 53
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Design Change
Distribution
CA, AZ, NV, NV, CO
Lot / Code Info
Catalog numbers, 11911, 11912, 11913, 11914, 11930, 11931
Root Cause
Other
Action Taken
Notify all implanting physicians of the removal and weight restrictions, and to evaluate thier patients for adherence to the weight restriction.
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