Z-0017-04

TC-PLUS Solution Tibial Component-- Symmetric

Name: Z-0017-04 TC-PLUS Solution Tibial Component-- Symmetric
Creator: Plus Endoprothetik AG
Published: 2003-04-17
License: https://open.fda.gov/license/

Plus Endoprothetik AG / initiated 2003-04-17 / Terminated / root cause: labeling and UDI

FDA source

Plus Endoprothetik AG began a recall of TC-PLUS Solution Tibial Component-- Symmetric on 2003-04-17. The reason FDA records is "Labeling/packaging mix-up". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0017-04
Status: Terminated
Initiated: 2003-04-17
Posted: 2003-10-15
Terminated: 2003-12-03
Recalling firm: Plus Endoprothetik AG
Product: TC-PLUS Solution Tibial Component-- Symmetric
Reason for recall: Labeling/packaging mix-up.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 15
Distribution: TX, CA, VA, ID, NY, UT, FL
Product codes and lots: Lot 0211.13.4553

K000666Class IITc-Plus Solution KneePlus Orthopedics / cleared 2000-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)