LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1524-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1529-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1553-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1517-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1525-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1519-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1552-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1512-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1527-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1507-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1510-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1518-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1532-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1521-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1551-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1513-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1537-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1511-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1534-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1522-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1540-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1541-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1554-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1530-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...