EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended...
FDA Recall #Z-0970-2015 — Class II — December 1, 2014
Product Description
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.
Reason for Recall
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.
Recalling Firm
Stelkast Co — Mcmurray, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
553
Distribution
TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.