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Recall Observatory FDA recall evidence

Device product

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

Z-2067-2023

December 23, 2022

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 92496
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-2067-2023

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: 04026575257393 Lot Number: 2123233

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).