Z-0018-06

TC-PLUS Tibial Insert UC 6; 13mm, Model 25438

Name: Z-0018-06 TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
Creator: Plus Orthopedics USA
Published: 2005-08-03
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2005-08-03 / Terminated

FDA source

Plus Orthopedics USA began a recall of TC-PLUS Tibial Insert UC 6; 13mm, Model 25438 on 2005-08-03. The reason FDA records is "Did not meet specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0018-06
Status: Terminated
Initiated: 2005-08-03
Posted: 2005-10-07
Terminated: 2006-06-16
Recalling firm: Plus Orthopedics
Product: TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Did not meet specifications.
FDA root cause: Other
Action: Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.
Quantity in commerce: 49
Distribution: Arizona, California, Idaho, New York, Texas, and Virginia
Product codes and lots: Lot code: 0501.13.0199, 0303.13.1616

Product code JWH

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)