Z-2067-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- December 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Reason for Recall
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).
Distribution Pattern
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Code Information
UDI-DI: 04026575257393 Lot Number: 2123233