The Recall Desk
HighFDA (Devices)·Z-2067-2023·Announced 2023-07-12

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.

What this means for you

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)
Category
Medical Device — Orthopedic Implant
Hazard
  • manufacturing-defect
  • implant-malfunction

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

Distributed nationwide across the United States.

Related recalls

Same category