Z-3018-2017 Class II Terminated
FDA device recall Z-3018-2017 was initiated by Exactech, Inc. on Jun 23, 2017 and is designated Class II. Reason for recall: The Truliant Tibial Trial Handle's pin may disassociate from the main body. The recall status is terminated (terminated Nov 30, 2020). Affected quantity: 68 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 23, 2017
- Initiation Date
- Jun 23, 2017
- Termination Date
- Nov 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 devices
Product Description
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
Reason for Recall
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Distribution Pattern
US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Code Information
Catalog Number 02-029-29-1000, Lot Number 83843-001.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3018-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026