The Recall Desk
HighFDA (Devices)·Z-1511-2023·Announced 2023-05-10

Knee implant tibial component recalled for aseptic loosening risk

Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or 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 orthopedic implant recall involving risk of aseptic loosening and implant wear that could necessitate revision surgery. No hospitalizations or injuries have been reported, making this a risk-of-harm product without yet-reported actual harm.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT (7MM X 45MM, Item Number 15-2028/01) due to risks of early aseptic loosening and increased implant wear.

The recall was initiated because the implant component can loosen or wear prematurely if positioned suboptimally or cemented inadequately during surgery. These issues can lead to unsatisfactory surgical outcomes and may require intervention or revision surgery sooner than expected.

Fourteen units have been distributed to locations in New York and Nevada, as well as internationally to 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 affected.

Linkbio Corp. is reinforcing surgical technique guidance and providing updated product training to address proper implant positioning and cementing technique. Healthcare providers should review the updated surgical guidelines.

The recalled product

Product
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic / Knee Implant
Hazard
Affected units
14

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: 04026575043934 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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