Z-0126-06
TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8
Plus Orthopedics / initiated 2005-02-22 / Terminated / root cause: labeling and UDI
Plus Orthopedics USA began a recall of TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8 on . The reason FDA records is "Labeling discrepancy". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0126-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Plus Orthopedics
- Product
- TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- Labeling discrepancy.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.
- Quantity in commerce
- 1 unit
- Distribution
- NY
- Product codes and lots
- Exp Date of 2011. No serial number. Lot number 0411.13.6556.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.