Z-3209-2018 Class II Ongoing
FDA device recall Z-3209-2018 was initiated by Exactech, Inc. on May 8, 2018 and is designated Class II. Reason for recall: Potentially have non-conforming internal threads. The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- May 8, 2018
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3209-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026