Stelkast Co 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stelkast Co
Lot Codes / Batch Numbers
part numbers SC3425 and SC3453
Products Sold
part numbers SC3425 and SC3453, with lot numbers:28592-103112 28593-102412 28602-110112 28603-110112 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31031-121013 31033-121013 31040-121013 31249-022514 31261-020414 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31040-121013 31043-120913 31243-022414 31244-022414 31249-022514 31252-021314 31255-020414 31261-020414 32083-080714 31028-120913 31031-121013 31032-121013 31033-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31034-120913 31040-121013 31043-120913 31044-120913 31249-022514 31255-020414 32083-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31028-120913 31029-120913 31031-121013 31032-121013 31033-121013 31034-120913 31037-121013 31040-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31249-022514 31252-021314 31255-020414 31261-020414 31263-021314 31265-031114 32081-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28613-110112 28622-112812 28623-112812 28624-112812 31034-120913 28599-111412 28617-110112 31028-120913 31032-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31249-022514 31251-022514 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28618-110112 28592-103112 28598-103112 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812
Stelkast Co is recalling EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended fo due to 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. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, IL, IN, KS, MD, NY, PA, TX, WA
Page updated: Jan 14, 2026