FDA-Device2015-01-21Class II
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 sufficient bone stock and soft tissue integrity are present.
Stelkast Co
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.
Sold states
TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
Affected count
553
Manufactured in
200 Hidden Valley Rd, Mcmurray, PA, United States
Products
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 sufficient bone stock and soft tissue integrity are present.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2015Don't want to check this manually?
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