CLASS II Device recall · Reported 23 Aug 2017 · FDA Enforcement Report
Truliant Tibial Trial Handle recalled by Exactech
Exactech is recalling Truliant Tibial Trial Handle, distributed in 11 states. The recall was initiated on 23 Jun 2017 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-3018-2017
- FDA event ID
- 77592
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2017
- FDA classified
- 11 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 23 Jun 2017 | Recall initiated by company | |
| 11 Aug 2017 | Classified by FDA | +49 days |
| 23 Aug 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Product as listed by the FDA
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle
Where it was distributed
US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
ArizonaCaliforniaColoradoFloridaIllinoisNevadaNew YorkOhioOklahomaSouth CarolinaTennessee
Questions about this recall
Is Truliant Tibial Trial Handle recalled?
Yes. Exactech recalled Truliant Tibial Trial Handle on 23 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-3018-2017.
Why was it recalled?
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Which lots are affected?
Catalog Number 02-029-29-1000, Lot Number 83843-001.
Where was it sold?
US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
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.
More recalls from Exactech
All 197| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Equinoxe Core Instrument Kit recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Ergo Modular Impactor Handle recalled by Exactech | Exactech | Other | 19 states |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Ergo Augments Pilot Tip Converter recalled by Exactech | Exactech | Device Malfunction | SC |
| Device | CLASS II | Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech | Exactech | Device Malfunction | SC |
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 |