The Recall Desk
HighFDA (Devices)·Z-1517-2023·Announced 2023-05-10

LINK SLED Knee Implant Component Recalled Due to Loosening

Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.

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 involving risk of implant failure (aseptic loosening, increased wear) that may require revision surgery. No hospitalizations or injuries are reported in the source, placing this at the High level per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System: ALL POLY TIBIAL COMPONENT (Item Number 15-2028/07) due to risk of early aseptic loosening and increased wear of the implant.

The recall addresses implant positioning and cementing technique issues. When the implant is positioned suboptimally or cemented inadequately, it may result in early aseptic loosening or increased wear, leading to unsatisfactory surgical outcomes and potentially requiring intervention or revision surgery earlier than expected.

Affected units are distributed in New York and Nevada, as well as internationally in 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. A total of 19 units were involved in this recall.

Linkbio Corp. has amended surgical technique documentation and will provide updated training on the corrected technique to address the issue.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
19

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: 04026575043996 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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