Z-0149-2007

Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226

Name: Z-0149-2007 Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
Creator: Plus Orthopedics USA
Published: 2006-06-20
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2006-06-20 / Terminated / root cause: manufacturing process

FDA source

Plus Orthopedics USA began a recall of Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226 on 2006-06-20. The reason FDA records is "Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0149-2007
Status: Terminated
Initiated: 2006-06-20
Posted: 2006-11-08
Terminated: 2007-12-13
Recalling firm: Plus Orthopedics
Product: Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Notification will take place to the wholesale (agent) level via telephone calls from PLUS USA''s Customer Service Department on/or about June 20, 2006. Each location will be contacted to determine if they have any affected devices. If so, they will be issued an RMA with the request to return any affected devices as soon as possible. Returned devices will be sent to the manufacturer for repair.
Quantity in commerce: 31
Distribution: Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI
Product codes and lots: All units

Product code HAW

K020298Class IIGalileo Cas/nav Tkr SystemPlus Orthopedics / cleared 2002-05-20

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)