LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation
Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.
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 a Class II FDA recall involving a manufacturing defect in a surgical implant. While no illnesses or injuries have been reported, the incorrect screw orientation poses a risk of device malfunction during or after implantation, meeting the criteria for High severity.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling the LinkSymphoKnee Distal Femoral Augment, Size 7-8 (Lateral-Right/Medial-Left, 5mm), intended for primary and revision total knee replacement in skeletally mature patients. The affected lot is 2123233, containing 20 units.
The fixation screw in the affected augments was inserted through the wrong side of the device—distal to proximal—rather than the correct orientation of proximal to distal. This manufacturing defect could affect the proper functioning of the surgical implant during and after knee replacement surgery.
The product was distributed nationwide to surgical facilities in Alabama, Illinois, Indiana, Louisiana, Georgia, Nevada, and Texas. Patients who have received these augments or healthcare providers who may have these devices in inventory should contact Waldemar Link GmbH & Co. KG. Healthcare providers should review their inventory using the UDI-DI (04026575257393) and Lot Number (2123233) to identify affected units.
The recalled product
- 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
- 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: 04026575257393 Lot Number: 2123233
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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