CLASS II Device recall · Reported 1 May 2019 · FDA Enforcement Report
Truliant Tibial Fit Tray Cemented SZ 3F / 3T recalled by Exactech
Exactech is recalling Truliant Tibial Fit Tray Cemented SZ 3F / 3T, distributed nationwide in the US. The recall was initiated on 13 Mar 2019 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-1208-2019
- FDA event ID
- 82480
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2019
- FDA classified
- 23 Apr 2019
- Reported
- 1 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 13 Mar 2019 | Recall initiated by company | |
| 23 Apr 2019 | Classified by FDA | +41 days |
| 1 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
2.5 Truliant Fit Trays were mismarked as 3
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are 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 Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
Nationwide ArkansasCaliforniaFloridaIndianaMinnesotaNew JerseyOhioOklahomaSouth CarolinaTennessee
Questions about this recall
Is Truliant Tibial Fit Tray Cemented SZ 3F / 3T recalled?
Yes. Exactech recalled Truliant Tibial Fit Tray Cemented SZ 3F / 3T on 13 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1208-2019.
Why was it recalled?
2.5 Truliant Fit Trays were mismarked as 3
Which lots are affected?
Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543
Where was it sold?
US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
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 |