| 2026-03-12 |
Class II
|
Ongoing |
Z-1810-2026 |
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 screen. |
| 2023-04-25 |
Class II
|
Ongoing |
Z-1674-2023 |
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for pr… |
— |
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Media… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1554-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1553-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1552-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1551-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1550-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1549-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1548-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1547-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1546-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1545-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1544-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1543-2023 |
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1542-2023 |
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1541-2023 |
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1540-2023 |
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1539-2023 |
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1538-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1537-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1536-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1535-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1534-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1533-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1532-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1531-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1530-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1529-2023 |
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1528-2023 |
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1527-2023 |
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1526-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1525-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1524-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1523-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1522-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1521-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1520-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1519-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1518-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1517-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1516-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1515-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1514-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1513-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1512-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1511-2023 |
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1510-2023 |
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1509-2023 |
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1508-2023 |
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1507-2023 |
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 |
— |
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen… |