TC-PLUS Solution Femoral Component, model 21028, Femoral… recallZ-0126-06 · Plus Orthopedics USA · initiated Feb 22, 2005
Terminated All recalls posted in November 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Plus Orthopedics USA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling discrepancy.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0126-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 22, 2005
- Posted by the FDA
- Nov 3, 2005
- Recalling firm
- Plus Orthopedics USA
- Quantity
- 1 unit
- Product code
- JWH
- FDA submissions
- K000666
- Distribution
- NY
Product description
TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
Code information (models, lots, serial numbers)
Exp Date of 2011. No serial number. Lot number 0411.13.6556.
Other devices under the same FDA submission
3 devices cleared under K000666 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TC-PLUS 75005997Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- TC-PLUS 75006076Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- TC-PLUS 75005186Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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