Linkbio Corp.
Medical device manufacturer in Rockaway, NJ.
2510(k) clearances
0PMA approvals
50recalls
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1810-2026 Class II | LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu… | 03/12/2026Open, Classified |
| Z-1674-2023 Class II | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6…Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the… | 04/25/2023Open, Classified |
| Z-1554-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1553-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1552-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1551-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1550-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1549-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1548-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1547-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1546-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1545-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1544-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1543-2023 Class II | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number:…Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1542-2023 Class II | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1541-2023 Class II | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1540-2023 Class II | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1539-2023 Class II | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1538-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1537-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1536-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1535-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1534-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1533-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1532-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1531-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1530-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1529-2023 Class II | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1528-2023 Class II | LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1527-2023 Class II | LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1526-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1525-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1524-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1523-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1522-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1521-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1520-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1519-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1518-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1517-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1516-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1515-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1514-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1513-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1512-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1511-2023 Class II | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1510-2023 Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1509-2023 Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1508-2023 Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |
| Z-1507-2023 Class II | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training… | 03/21/2023Open, Classified |