The Recall Desk
HighFDA (Devices)·Z-1528-2023·Announced 2023-05-10

LINK SLED Knee System tibial component recall for aseptic loosening and wear risk

Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.

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 for structural implant defect (aseptic loosening and wear) with potential for patient harm requiring revision surgery. No reported injuries or hospitalizations are explicitly stated in the source, limiting severity to High per the rubric.

Plain-English summary

Linkbio Corp. is recalling 15 units of the LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP (Item Number 15-2030/03) distributed in New York, Nevada, and multiple countries worldwide.

The recall addresses a risk of early aseptic loosening or increased wear of the implant. This risk arises from suboptimal positioning of the implant during surgery or inadequate cementing technique. Both can lead to unsatisfactory surgical results and may require intervention or revision surgery earlier than expected.

In response, Linkbio Corp. is issuing amendments to surgical technique guidelines and conducting updated product training to reinforce proper implant positioning and cementing procedures.

Patients who received this implant should contact their healthcare provider to discuss their individual risk. Healthcare providers using this product should review the updated surgical technique guidance.

The recalled product

Product
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03
Manufacturer
Linkbio Corp.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
15

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: 04026575044078 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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