The Recall Desk
HighFDA (Devices)·Z-1523-2023·Announced 2023-05-10

LINK SLED Knee System tibial component recall due to implant positioning and cementing concerns

Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.

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 Class II FDA recall for a surgical implant with theoretical risk of early failure requiring revision surgery. No reported illnesses or hospitalizations are documented in the source. Per the rubric, recalls for risk-of-harm products where injury has not yet been reported score at most 3 (High).

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT 7MM X 58MM (Item 15-2028/13, UDI-DI: 04026575359455) affecting 18 units distributed in New York, Nevada, 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.

The recall addresses the risk of early aseptic loosening or increased wear of the implant. These issues are caused by suboptimal positioning of the implant during surgery or inadequate cementing technique. Either condition can lead to an unsatisfactory surgical result and, in the worst case, may require earlier-than-expected intervention or revision surgery.

Linkbio is responding to this Class II recall by reinforcing surgical technique guidance and providing updated product training. Surgeons and healthcare facilities using this component should review the updated surgical technique guidance and ensure all relevant staff receive the latest training.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
  • aseptic-loosening
  • implant-wear
  • implant-failure

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: 04026575359455 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category