UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
This recall has been terminated (originally issued February 15, 2005).
- Company
- Plus Orthopedics
- Recall Initiated
- January 4, 2005
- Posted
- February 15, 2005
- Terminated
- March 3, 2005
- Recall Number
- Z-0540-05
- Quantity
- 10, 1 is implanted.
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Knee tibial insert is mislabeled completely as different device.
Distribution
California, Idaho, Illinois, Wisconsin, Oregon
Lot / Code Info
All of specific lot 044843
Root Cause
Other
Action Taken
PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.
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