Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2023 - (Recall #: Z-2067-2023)

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, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21

Product Classification:

Class II

Date Initiated: December 23, 2022

Date Posted: July 12, 2023

Recall Number: Z-2067-2023

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: 04026575257393 Lot Number: 2123233

Distribution Pattern:

US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.

Voluntary or Mandated:

Voluntary: Firm initiated