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Terminated

Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226

FDA Recall Z-0149-2007 · Posted 2006-11-08

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeHAW
Date Initiated2006-06-20
Date Terminated2007-12-13
Product Quantity31

Reason for Recall

Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020298GALILEO CAS/NAV TKR SYSTEMPlus Orthopedics · 2002-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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