FDA recall record · openFDA
Linkbio Corp.
50 FDA recalls on record (2023–2026) — 50 device. 50 still ongoing.
0
Class I (most serious)
50
Class II
0
Class III
50
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the update 48
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (La 1
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. 1
Recalls
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. Class II 2026-03-12 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07 Class II 2023-03-21 LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for pr Class II 2023-04-25 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11 Class II 2023-03-21 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52 Class II 2023-03-21 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40 Class II 2023-03-21 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03 Class II 2023-03-21 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15 Class II 2023-03-21 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13 Class II 2023-03-21 LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03 Class II 2023-03-21 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12 Class II 2023-03-21 LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02 Class II 2023-03-21 LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14 Class II 2023-03-21 LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60 Class II 2023-03-21 LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04 Class II 2023-03-21 LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08 Class II 2023-03-21
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.