The Recall Desk
HighFDA (Devices)·Z-1520-2023·Announced 2023-05-10

LINK SLED Knee Implant Component Recalled for Early Aseptic Loosening Risk

Linkbio Corp. is recalling 13 units of the LINK SLED Knee Implant All Poly Tibial Component due to risk of early aseptic loosening from suboptimal surgical positioning or inadequate cementing technique. Updated surgical technique guidance is being provided to prevent premature implant failure.

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 of a surgical implant with potential for early aseptic loosening and possible need for revision surgery. No specific patient injuries are reported in the source text, but it represents a risk-of-harm scenario involving a serious medical device complication.

Plain-English summary

Linkbio Corp. is recalling 13 units of the LINK SLED Knee System All Poly Tibial Component (9MM X 55MM, Item Number 15-2028/10), a tibial (shin bone) implant used in knee replacement surgery.

The recall was issued because the implant may experience early aseptic loosening or increased wear due to suboptimal positioning during surgery or inadequate cementing technique. Aseptic loosening is when an implant becomes loose without infection. This can lead to an unsatisfactory surgical result and may require intervention or revision surgery earlier than expected.

The affected devices were distributed in 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 included in this recall (UDI-DI: 04026575044023).

Linkbio Corp. is issuing amended surgical technique guidance and future product training to ensure proper implant positioning and cementing. Healthcare providers should review this guidance and implement the updated surgical technique. Patients who have received this implant should consult with their surgeon regarding their individual situation and any potential follow-up needs.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
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: 04026575044023 All lot numbers within the labeled expiration date

Distribution

Distributed in 2 states:

  • NV
  • NY

Related recalls

Same category