Truliant Splined Stem Extension — Class II medical device recall Z-1364-2020
Ongoing recall by Exactech, Inc., reported 2020-03-04, distributed nationwide. These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corne
| Recall number | Z-1364-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2020-01-27 |
| Classified | 2020-02-26 |
| Reported by FDA | 2020-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | labeling |
| Serial numbers | 6366405, 6367075, 6367076 |
| Model numbers | 02-012-64-1812 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1364-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.