FDA-Device2018-09-26Class II
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
Exactech, Inc.
Hazard
Potentially have non-conforming internal threads.
Sold states
US Distribution to Ohio only.
Affected count
1
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3209-2018Don't want to check this manually?
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