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Stelkast Co recalls EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee rep
Recalled January 21, 2015 · FDA recall Z-0970-2015 · Stelkast
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. · FDA Class II
Units
553
Sold at
TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
Description
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.
Product
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.
Manufacturer(s)
Stelkast Co
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →