FDAFDA · Food and drugs·Recall number Z-3209-2018
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.
Published September 26, 2018 · Recall initiated: May 8, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potentially have non-conforming internal threads.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- US Distribution to Ohio only.
- Lot
- Catalog #: 02-012-60-2216 Serial Number: 5370045
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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