The Recall Desk
HighFDA (Devices)·Z-1519-2023·Announced 2023-05-10

LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT due to risk of early aseptic loosening or increased wear from suboptimal surgical placement or cementing, which may require early revision surgery.

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: FDA Class II medical device with risk of implant failure and early revision surgery required, but no actual illnesses or injuries have been reported. Per the rubric, when hazards are theoretical with no reported injuries, the maximum score is 3.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item 15-2028/09) due to risk of early aseptic loosening or increased wear of the implant. The issue stems from suboptimal positioning of the implant or inadequate cementing technique during surgery, which can result in an unsatisfactory surgical outcome.

In the worst case, early implant failure may require revision surgery sooner than expected. The FDA has classified this as a Class II recall. All lot numbers of the affected component are involved.

Patients who have received this implant component should contact their surgeon or healthcare provider if they experience unusual knee pain, swelling, instability, or other signs of implant complications. Surgeons using this system should review the updated surgical technique and training materials provided by the manufacturer.

The affected component was distributed in the United States (NY, NV) and internationally to Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus. Approximately 12 units were distributed.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Knee Implant
Hazard
Affected units
12

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: 04026575044016 All lot numbers

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 48 recalled by Linkbio Corp. 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.

See all 48 products in this recall →

Related recalls

Same manufacturer · Linkbio Corp.

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Same hazard · aseptic loosening

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