The Recall Desk
HighFDA (Devices)·Z-1538-2023·Announced 2023-05-10

LINK SLED Knee Implant Component Recalled for Aseptic Loosening Risk

The LINK SLED Knee System tibial component is being recalled due to risk of aseptic loosening caused by improper implant positioning or cementing technique, which could lead to early implant failure requiring 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 recall of an orthopedic implant component with risk of aseptic loosening and premature failure. No reported adverse events or patient injuries are documented; the recall reflects a proactive correction of surgical technique to prevent early implant failure and potential revision surgery.

Plain-English summary

The LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP (8 MM X 55 MM, Item Number 15-2030/15) is being recalled by Linkbio Corp. This component is part of a knee replacement system used in orthopedic surgical procedures.

The recall was initiated due to risk of early aseptic loosening and increased wear of the implant caused by suboptimal positioning during implant placement or inadequate cementing technique. These factors can lead to unsatisfactory surgical results and, in the worst case, may require early intervention or revision surgery.

Sixteen units of the recalled component were distributed to New York and Nevada, as well as 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. All lot numbers within the labeled expiration date are affected.

Patients who have received this implant component should consult with their orthopedic surgeon to discuss any concerns and to understand whether additional monitoring or revision may be appropriate. Healthcare providers should implement the updated surgical technique training provided by Linkbio Corp. and ensure proper implant positioning and cementing technique for future procedures.

The recalled product

Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic / Joint Replacement
Hazard
Affected units
16

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: 04026575436729 All lot numbers within the labeled expiration date

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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