TC-PLUS Solution Tibial Component-- Symmetric recallZ-0017-04 · Plus Endoprothetik AG · initiated Apr 17, 2003
Terminated All recalls posted in October 2003
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 Endoprothetik AG 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/packaging mix-up.
FDA root cause category: Other
What the company is doing
Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.
Recall details
- Recall number
- Z-0017-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 17, 2003
- Posted by the FDA
- Oct 15, 2003
- Recalling firm
- Plus Endoprothetik AG
- Quantity
- 15
- FDA submissions
- K000666
- Distribution
- TX, CA, VA, ID, NY, UT, FL
Product description
TC-PLUS Solution Tibial Component-- Symmetric
Code information (models, lots, serial numbers)
Lot 0211.13.4553
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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