Device product
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Z-2066-2023
Product summary
- Event
- Event 92496
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-2066-2023
Official wording
Reason: Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Code information: UDI-DI: 04026575257379 Lot Number: 2123225
Distribution pattern: US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Derived failure modes
-
Unknown
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).