The Recall Desk
HighFDA (Devices)·Z-1674-2023·Announced 2023-06-07

LINK SymphoKnee System Femoral Augment Recalled for Incorrect Implant in Packaging

Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment because the packaging contains the opposite side of the implant. This error could result in implantation of the wrong component if not detected.

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 risk-of-harm medical device recall where an incorrect component is present in packaging. While classified as FDA Class II, no illnesses or injuries have been reported. The hazard—implantation of the wrong implant side—could compromise surgical outcomes if the error is not detected before use.

Plain-English summary

Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment (Item Number 880-325/13, Lot Number 1910003) used in primary and revision total knee replacement procedures.

The packaging for this knee replacement augment incorrectly contains the opposite side of the implant. Specifically, the packaging contains the Lateral-Right/Medial-Left component instead of the Medial-Right/Lateral-Left component that is indicated on the package. This packaging error could result in implantation of the incorrect implant component during knee replacement surgery.

The affected units were distributed nationwide to healthcare facilities in Alabama, Georgia, Illinois, Indiana, Louisiana, Nevada, and Texas.

The recalled product

Product
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Manufacturer
Linkbio Corp.
Category
Medical Device — Knee replacement
Hazard
  • wrong-component
  • packaging-error

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 : 04026575258123 Lot Number: 1910003

Distribution

Distributed nationwide across the United States.

Related recalls

Same category