The Recall Desk
HighFDA (Devices)·Z-1550-2023·Announced 2023-05-10

LINK SLED Knee Implant Recall for Aseptic Loosening Risk

The LINK SLED Knee System POREX ENDO tibial implant is recalled due to risk of early aseptic loosening or increased wear from suboptimal positioning or inadequate cementing. Affected patients may require early 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: FDA Class II recall with no reported hospitalizations or illnesses. The hazard—premature implant loosening and wear—represents a risk-of-harm without reported patient injury, placing this at Score 3 per the rubric criterion for risk-based medical device recalls.

Plain-English summary

The LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP (11 MM X 55 MM, Item Number 15-2230/11) is recalled by Linkbio Corp. Three units were distributed to hospitals in New York and Nevada, with additional international distribution.

The implant poses a risk of early aseptic loosening or increased wear if positioned suboptimally during surgery or if cementing technique is inadequate. This can lead to an unsatisfactory surgical result and, in worst-case scenarios, may require early revision surgery.

The FDA is requiring amended product labeling and updated surgical technique training from the manufacturer. Healthcare providers should ensure proper implant positioning and appropriate cementing technique during surgery. Patients with this implant should contact their healthcare provider with any concerns.

The recalled product

Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant / Knee
Hazard
Affected units
3

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: 04026575429219 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

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