Z-2067-2023 Class II Ongoing
FDA device recall Z-2067-2023 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on Dec 23, 2022 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 12, 2023
- Initiation Date
- Dec 23, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2067-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026