Linkbio Corp.

FDA Regulatory Profile

Summary

Total Recalls
49
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1674-2023Class IILINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cementApril 25, 2023
Z-1552-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13March 21, 2023
Z-1541-2023Class IILINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52March 21, 2023
Z-1529-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04March 21, 2023
Z-1531-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07March 21, 2023
Z-1534-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11March 21, 2023
Z-1549-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10March 21, 2023
Z-1512-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02March 21, 2023
Z-1536-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13March 21, 2023
Z-1538-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15March 21, 2023
Z-1551-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12March 21, 2023
Z-1524-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14March 21, 2023
Z-1550-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11March 21, 2023
Z-1554-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15March 21, 2023
Z-1522-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12March 21, 2023
Z-1510-2023Class IILINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60March 21, 2023
Z-1530-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06March 21, 2023
Z-1520-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10March 21, 2023
Z-1525-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15March 21, 2023
Z-1543-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02March 21, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K241470CORE Shoulder SystemFebruary 20, 2025
K190181Instruments for LINK MEGASYSTEM-C FamilyOctober 25, 2019