FDADecember 1, 2014device
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where suffici...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
What to do
FDA enforcement status: Terminated
Brands named
stelkast
UPCs
285921031122859310241228602110112286031101122861311011228617110112286181101122862211281228623112812286241128123103112101331033121013
Recall history
No related federal recalls on record for this brand yet.
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