Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8 Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to Fixation screw was inserted through the wrong side...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.
Affected Products
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
Quantity: 20 units
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Waldemar Link GmbH & Co. KG (Mfg Site)
Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report