Z-3209-2018 Class II Ongoing

Recalled by Exactech, Inc. — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
May 8, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

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.

Distribution Pattern

US Distribution to Ohio only.

Code Information

Catalog #: 02-012-60-2216 Serial Number: 5370045