FDAApril 25, 2023device
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
What to do
FDA enforcement status: Ongoing
Brands named
linkbio
UPCs
04026575258123
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.2026-03-12
- FDALINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/022023-03-21
- FDALINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/152023-03-21
- FDALINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/062023-03-21
- FDALINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/132023-03-21
- FDALINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/142023-03-21
- FDALINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/042023-03-21
- FDALINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/162023-03-21
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