The Recall Desk
HighFDA (Devices)·Z-1552-2023·Announced 2023-05-10

Knee Implant Recall for Aseptic Loosening and Implant Wear Risk

The LINK SLED Knee System is recalled due to risk of early aseptic loosening and implant wear caused by suboptimal surgical positioning or inadequate cementing. The manufacturer is updating surgical guidance and providing 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: FDA Class II medical device with risk of implant loosening and early revision surgery, but no reported illnesses or injuries. Matches rubric criterion for High (3): risk-of-harm product where injury has not yet been reported.

Plain-English summary

The LINK SLED Knee System POREX ENDO Model (Item Number 15-2230/13) has been recalled by the U.S. Food and Drug Administration due to risk of early aseptic loosening and increased wear of the implant. The recall affects all lot numbers within the labeled expiration date.

Five units have been distributed to patients in New York and Nevada, with additional distribution in 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.

The hazard arises from suboptimal positioning of the implant or inadequate cementing techniques during surgical implantation. This can lead to unsatisfactory surgical results and may require earlier-than-expected revision surgery. The manufacturer is amending surgical technique guidance and providing additional training on proper implantation and cementing procedures.

Patients with this implant should contact their surgeon or healthcare provider to discuss their individual situation and any follow-up monitoring needs.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
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: 04026575436736 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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