LinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement
The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect—improper screw insertion orientation in a surgical implant. While the defect poses a risk of implant instability or failure, no illnesses or injuries have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Waldemar Link GmbH & Co. KG has recalled the LinkSymphoKnee Distal Femoral Augment (Size 7-8, Medial-Right/Lateral Left, 5mm) for use in primary and revision total knee replacement surgery. The recall affects 20 units distributed nationwide.
The product is being recalled because fixation screws were inserted through the wrong side of the augment—inserted distally to proximally rather than the correct proximal to distal orientation. This manufacturing error could compromise the implant's structural integrity and function.
The recalled units were distributed to facilities in Alabama, Georgia, Illinois, Indiana, Louisiana, Nevada, and Texas. The affected lot number is 2123225 (UDI-DI: 04026575257379).
Patients who have received this implant or healthcare providers who have implanted units from the affected lot should contact Waldemar Link for guidance on further evaluation and potential replacement.
The recalled product
- Product
- 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
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04026575257379 Lot Number: 2123225
Distribution
Part of a larger recall action
This product is one of 2 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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