The Recall Desk
HighFDA (Devices)·Z-1526-2023·Announced 2023-05-10

LINK SLED Knee Implant System recalled for early aseptic loosening

The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (18 units) is recalled due to early aseptic loosening and increased wear caused by suboptimal positioning or inadequate cementing technique, which may require earlier-than-expected 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: This is a Class II device recall for a risk-of-harm product (orthopedic implant with aseptic loosening failure mode) where injury has not been reported. The hazard is real and may require surgical intervention, but no illnesses or injuries are reported in the source text.

Plain-English summary

The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (Item Number 15-2028/16) is being recalled by Linkbio Corp. following identification of early aseptic loosening and increased wear of the implant component. The issue is caused by suboptimal positioning of the implant or inadequate cementing technique during surgical placement.

The recall affects 18 units distributed to New York, Nevada, and multiple countries including Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, the 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 the recall.

Loose or worn implants can lead to unsatisfactory surgical results and may require patients to undergo earlier-than-expected revision or replacement surgery. Linkbio Corp. is providing updated surgical technique guidance and training to help prevent this complication. Patients and surgeons with this implant should review the updated guidance and consult with their healthcare provider to determine appropriate monitoring or follow-up care.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
18

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: 04026575359486 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.

See all →

Same hazard · aseptic loosening

See all →