Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-1364-2020

U.S. FDA — Device Enforcement · United States · 2020-01-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1364-2020
Date of alert: 2020-01-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Exactech, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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