Z-0540-05

UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm

Name: Z-0540-05 UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
Creator: Plus Orthopedics
Published: 2005-01-04
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2005-01-04 / Terminated / root cause: labeling and UDI

FDA source

Plus Orthopedics began a recall of UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm on 2005-01-04. The reason FDA records is "Knee tibial insert is mislabeled completely as different device". 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-0540-05
Status: Terminated
Initiated: 2005-01-04
Posted: 2005-02-15
Terminated: 2005-03-03
Recalling firm: Plus Orthopedics
Product: UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Knee tibial insert is mislabeled completely as different device.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.
Quantity in commerce: 10, 1 is implanted.
Distribution: California, Idaho, Illinois, Wisconsin, Oregon
Product codes and lots: All of specific lot 044843

Product code JWH

K022204Class IIVks Knee SystemPlus Orthopedics / cleared 2002-10-18

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)