CLASS II ONGOING Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Optetrak Logic CC Stem Extension The Optetrak Logic CC recalled
Exactech is recalling Optetrak Logic CC Stem Extension The Optetrak Logic CC Total Knee System is indicated for, distributed in Ohio. The recall was initiated on 8 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3209-2018
- FDA event ID
- 80763
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2018
- FDA classified
- 20 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 8 May 2018 | Recall initiated by company | |
| 20 Sep 2018 | Classified by FDA | +135 days |
| 26 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potentially have non-conforming internal threads.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to Ohio only.
Questions about this recall
Is Optetrak Logic CC Stem Extension The Optetrak Logic CC Total Knee System is indicated for recalled?
Yes. Exactech recalled Optetrak Logic CC Stem Extension The Optetrak Logic CC Total Knee System is indicated for on 8 May 2018. The recall is Class II and its status is Ongoing. Recall number Z-3209-2018.
Why was it recalled?
Potentially have non-conforming internal threads.
Which lots are affected?
Catalog #: 02-012-60-2216 Serial Number: 5370045
Where was it sold?
US Distribution to Ohio only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |