LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Inte...
FDA Recall #Z-2066-2023 — Class II — December 23, 2022
Product Description
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
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).
Recalling Firm
Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20 units
Distribution
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Code Information
UDI-DI: 04026575257379 Lot Number: 2123225
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated