The Recall Desk
HighFDA (Devices)·Z-1516-2023·Announced 2023-05-10

LINK SLED Knee System tibial component subject to surgical technique amendment

A knee implant component is being recalled due to risks of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing. Manufacturers are providing updated surgical guidance.

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 recall with identified risk of early aseptic loosening and implant wear that could necessitate revision surgery. The source text does not report any patient injuries or deaths, placing this at the High level per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Linkbio Corp. is amending the labeling and providing reinforced surgical technique training for the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/06) due to concerns about early aseptic loosening and increased implant wear.

The amendment addresses the risk that suboptimal positioning of the implant or inadequate cementing technique during surgery can lead to early loosening or increased wear, potentially resulting in unsatisfactory surgical outcomes. In some cases, this could necessitate revision surgery or other intervention earlier than would be expected.

This amendment affects 15 units distributed in New York and Nevada within the United States, as well as 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. All lot numbers within the labeled expiration date are included.

Healthcare providers should implement the updated surgical technique guidance provided by the manufacturer to ensure proper implant positioning and cementing. Staff should complete the reinforced product training before using this device.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant - Knee System
Hazard
  • aseptic-loosening
  • implant-wear

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: 04026575043989 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category