PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: September 26, 2018 Initiated: May 8, 2018 #Z-3209-2018

Product Description

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.

Reason for Recall

Potentially have non-conforming internal threads.

Details

Recalling Firm
Exactech, Inc.
Units Affected
1
Distribution
US Distribution to Ohio only.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Exactech, Inc.. Units affected: 1.
Why was this product recalled?
Potentially have non-conforming internal threads.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3209-2018.