Z-1364-2020 Class II Ongoing
FDA device recall Z-1364-2020 was initiated by Exactech, Inc. on January 27, 2020 and is designated Class II. Reason for recall: These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant s… The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 27, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
Reason for Recall
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
Distribution Pattern
US Nationwide distribution in the states of AZ, CO and FL.
Code Information
Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076