Linkbio Corp. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 50.

Medical DeviceApr 22, 2026

LinkBio CORE Workstation, a component of the CORE Shoulder System recall — FDA Z-1810-2026

The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceJun 7, 2023

Linkbio LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 recall — FDA Z-1674-2023

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).

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13 recall — FDA Z-1523-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number recall — FDA Z-1550-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07 recall — FDA Z-1517-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number recall — FDA Z-1540-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number recall — FDA Z-1554-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11 recall — FDA Z-1521-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52 recall — FDA Z-1541-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40 recall — FDA Z-1539-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46 recall — FDA Z-1508-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number recall — FDA Z-1529-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16 recall — FDA Z-1526-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number recall — FDA Z-1546-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number recall — FDA Z-1543-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03 recall — FDA Z-1513-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60 recall — FDA Z-1510-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number recall — FDA Z-1548-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05 recall — FDA Z-1515-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06 recall — FDA Z-1516-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number recall — FDA Z-1534-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number recall — FDA Z-1552-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number recall — FDA Z-1530-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number recall — FDA Z-1531-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Understanding this recall history

This page summarizes recall records in which the official source identifies Linkbio Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.