Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2023 - (Recall #: Z-2066-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
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
Product Classification:
Class II
Date Initiated: December 23, 2022
Date Posted: July 12, 2023
Recall Number: Z-2066-2023
Event ID: 92496
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).
Status: Ongoing
Product Quantity: 20 units
Code Information:
UDI-DI: 04026575257379 Lot Number: 2123225
Distribution Pattern:
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Voluntary or Mandated:
Voluntary: Firm initiated