The Recall Desk
HighFDA (Devices)·Z-1551-2023·Announced 2023-05-10

Knee Implant Component Recalled for Risk of Early Aseptic Loosening

Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear caused by suboptimal implant positioning or inadequate 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: This is an FDA Class II recall involving risk of implant failure (aseptic loosening and accelerated wear) that could require revision surgery. No illnesses, injuries, or deaths have been reported. Per the rubric, this qualifies as High because it is a risk-of-harm medical device where injury has not yet been reported, but the potential outcome (revision surgery) is clinically significant.

Plain-English summary

Linkbio Corp. is recalling the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP (13 MM X 55 MM, Item Number 15-2230/12). Five units of this orthopedic implant component have been distributed.

The implant may experience early aseptic loosening or accelerated wear due to suboptimal positioning or inadequate cementing technique during surgery. These issues can result in an unsatisfactory surgical outcome and may necessitate revision surgery earlier than expected.

The recalled units were distributed to New York and Nevada in the United States, 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 with an expiration date within the labeled period are affected.

Linkbio Corp. is providing amended surgical technique guidance and product training reinforcement to address the issue. Healthcare providers should review and implement the updated surgical technique to ensure proper implant positioning and cementing.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic / Knee Implant
Hazard
Affected units
5

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: 04026575429226 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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