Food, drugs, devices › Exactech, Inc.
Device recall: Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to
FDA enforcement event 77592 is a device recall by Exactech, Inc. of Gainesville, FL, initiated 23 Jun 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 30 Nov 2020. Initiation: voluntary: firm initiated. Exactech, Inc. has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Exactech, Inc., Gainesville, FL.
Reason for recall
"The Truliant Tibial Trial Handle's pin may disassociate from the main body."
Distribution
"US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3018-2017 | 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 | 68 devices | Class II | Terminated | 23 Aug 2017 |
Context
Other enforcement events for Exactech, Inc.
All 61 events for Exactech, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Truliant Tibial Trial Handle's pin may disassociate from the main body."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.