Linkbio Corp. FDA Recalls

50 recalls on file across devices, 0 of them Class I and 50 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.Class IIMar 12, 2026The CORE Workstation may display an incorrect "Planning Date	The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu scr	Class IIDevices	Mar 12, 2026
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for prClass IIApr 25, 2023Contains the incorrect implant in the packaging. The packagi	Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the i	Class IIDevices	Apr 25, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04Class IIMar 21, 2023Additional Label Warnings: Amendment / reinforcement of the	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on	Class IIDevices	Mar 21, 2023