Z-0191-2007

UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral...

Name: Z-0191-2007 UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral...
Creator: Plus Orthopedics USA
Published: 2006-07-18
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2006-07-18 / Terminated

FDA source

Plus Orthopedics USA began a recall of UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6, 26008 Femoral Component Size 8 and... on 2006-07-18. The reason FDA records is "There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0191-2007
Status: Terminated
Initiated: 2006-07-18
Posted: 2006-11-16
Terminated: 2007-12-13
Recalling firm: Plus Orthopedics
Product: UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.
FDA root cause: Other
Action: The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
Quantity in commerce: 68
Distribution: California
Product codes and lots: Lot Number: All lots considered affected Serial Number: None

Product code HRY

K982859Class IIUc-Plus Solution Unicondylar Knee SystemPlus Orthopedics / cleared 1999-07-30

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)